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U.S. Department of Health and Human Services

Safety

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Instructions for Completing Form FDA 3500

Form FDA 3500 may be used by health professionals or consumers (see NOTE below) for VOLUNTARY reporting of adverse events, product use errors, product quality problems and therapeutic failures for:

  • drugs  (prescription and over-the-counter)
  • biologics,(including blood components, blood derivatives, allergenics, human cells, tissues, and cellular and tissue-based products (HCT/Ps)
  • medical devices (including in vitro diagnostic products)
  • combination products
  • special nutritional products (dietary supplements, infant formulas, medical foods)
  • cosmetics
  • foods/beverages (including reports of serious allergic reactions )

Adverse events involving vaccines should be reported to theVaccine Adverse Event Reporting System (VAERS), http://vaers.hhs.gov/index. For additional information or assistance with filing a VAERS report, call: 1-800-822-7967.

Adverse events involving investigational (study) drugs, such as those relating to Investigational New Drug (IND) applications, including those for cellular products administered under IND, should be reported as required in the study protocol and sent to the address and contact person listed in the study protocol. They should generally not be submitted to FDA MedWatch as voluntary reports.

NOTE FOR CONSUMERS/PATIENTS/CAREGIVERS:

FDA is now providing a voluntary reporting form, Form FDA 3500B, that is customized to make the completion of the form by non-health professionals or consumers easier. You may continue to use this Form FDA 3500, but can find a link to the new consumer form on the Medwatch homepage, www.fda.gov/medwatch.

If possible, please take the 3500 form to your health professional (e.g., doctor or pharmacist) so you can obtain information from your medical record that can help in the evaluation of your report. If, for whatever reason, you do not wish to have your health professional fill out the form, you are welcome to do so yourself.


GENERAL INSTRUCTIONS

  • Please send only Page 1 and any continuation pages you add.  You should not send the instruction pages.
  • Please make sure that all entries are typed, printed in a font no smaller than 8 point, or handwritten using black ink.
  • Please complete all sections that apply to your report.
  • Dates should be entered as mm/dd/yyyy (e.g., June 3, 2012 = 06/03/2012).
    If exact dates are unknown, please provide the best estimate (see B3).
  • For narrative entries, if the fields do not provide adequate space, attach additional pages as needed.
  • If attaching additional pages, please do the following:
    • Identify all attached pages as Page __ of __
    • Indicate the appropriate section and block number next to the narrative continuation
    • Include the phrase continued at the end of each field that has additional information continued onto another page
  • Section D, Suspect product[s], should be used to report on dietary supplements, infant formula, foods including beverages, and cosmetics as well as drugs or biologics, including human cells, tissues, and cellular and tissue-based products (HCT/Ps) and whole blood or blood components (for example, plasma, platelets, red blood cells).
  • If the case report involves more than two (2) suspect products, please prepare a complete copy of FDA Form 3500 that identifies the first two products and attach an additional copy of Form 3500, with only section D filled in, for each additional product.
  • If the case report involves more than one (1) suspect medical device, please prepare a complete copy of FDA Form 3500 that identifies one device and attach an additional copy of Form 3500, with only section E filled in, for each additional device.
  • If your report involves a serious adverse event with a device and it occurred in a device user facility (other than a doctor's office), that facility may be legally required to report to FDA and/or the manufacturer. Please notify the person in that facility who would handle such reporting.

For questions about specific products:


Product Type

E-mail Inquiries

Telephone Inquiries

Drugs

Drug Information Questions and Comments

druginfo@fda.hhs.gov

Division of Drug Information
(888) 463-6332
(301) 796-3400

Special Nutritional Products
(dietary supplements, infant formulas, medical foods), Cosmetics and Foods/Beverages

Food, Nutrition, and Cosmetics Questions & Answers

Email: Consumer@fda.gov

888-723-3366

Medical Devices

Center for Devices and Radiological Health, Division of Industry and Consumer Education (DICE)

Email: DICE@fda.hhs.gov

800-638-2041

Vaccines, blood products, other biologics

Center for Biologics Evaluation and Research,
Division of Communication and Consumer Affairs, Consumer Affairs Branch
Questions and Answers
Email: ocod@fda.hhs.gov

800-835-4709

Tobacco products

Center for Tobacco Products General Inquiries

Email:  AskCTP@fda.hhs.gov

1-877-CTP-1373 or 301-796-9200


INDEX

To read instructions for a specific section, click a link from the list below.
 

SECTION A: PATIENT INFORMATION
A1:     Patient Identifier
A2:     Age at Time of Event or Date of Birth
A3:     Sex
A4:     Weight

SECTION B: ADVERSE EVENT, PRODUCT PROBLEM OR ERROR
B1:     Adverse Event, Product Problem, Product Use Error or Problem with Different Manufacturer of Same Medicine
B2:     Outcomes Attributed to Adverse Event
B3:     Date of Event
B4:     Date of this Report
B5:     Describe Event,  Problem or Product Use Error
B6:     Relevant Tests/Laboratory Data, Including Dates 
B7:    Other Relevant History, Including Preexisting Medical Conditions
 

SECTION C: PRODUCT AVAILABILITY
C1: Product Available for Evaluation?

SECTION D: SUSPECT PRODUCT(S) (Space provided to identify two products)
D1:     Name, Strength, Manufacturer
D2:     Dose or Amount, Frequency, Route
D3:     Dates of Use
D4:     Diagnosis or Reason for Use
D5:     Event Abated After Use Stopped or Dose Reduced
D6:     Lot #
D7:     Expiration date
D8:     Event Reappeared After Reintroduction
D9:     NDC #  or Unique ID

SECTION E: SUSPECT MEDICAL DEVICE
E1:     Brand Name
E2:     Common Device Name 
E2b.  Procode
E3:     Manufacturer Name, City and State
E4:     Model #, Catalog #, Serial #, Lot #, Expiration Date, Unique Identifier (UDI) #
E5:     Operator of Device
E6:     If Implanted, Give Date 
E7:     If Explanted, Give Date
E8:     Is this a Single-use Device that was Reprocessed and Reused on a Patient?
E9:     Name and Address of Reprocessor

SECTION F: OTHER (CONCOMITANT) MEDICAL PRODUCTS

SECTION G: REPORTER
G1:     Name, Address, Phone #, Email
G2:     Health Professional?
G3:     Occupation
G4:     Also Reported to:
G5:     If you do NOT want your identity disclosed to the Manufacturer

APPENDIX I: ROUTES OF ADMINISTRATION: ICH LIST AND CODES


SECTION A: PATIENT INFORMATION
Submit a separate complete form for each patient, unless the report involves a medical device where multiple patients were adversely affected through the use of the same device. In that case, please prepare one complete FDA Form 3500 for one patient and indicate the number of patients in block B5 (Describe event or problem).  Then attach additional copies of Form 3500 with only Section A and blocks B2, B5, B6, B7, and F filled in for each additional patient.

Mother-infant/fetus report(s) are those cases in which either a mother or a fetus/breast-feeding infant, or both, have an adverse event that is possibly associated with a product administered to or device used on the mother during pregnancy. Several general principles are used for filing these reports:

  • If the event did not affect the infant/fetus, report only on the mother.
  • For those cases describing fetal death, miscarriage or abortion, report the mother as the patient in the report.
  • When only the infant/fetus has an adverse reaction/event (other than fetal death, miscarriage or abortion), the information provided in section A applies to the infant/fetus. However, the information in Section D or Section E would apply to the mother who was the source of exposure to the product or device.
  • When a newborn baby is found to have a birth defect/congenital anomaly that the initial reporter considers possibly associated with a product administered to or device used on the mother during pregnancy, the patient is the newborn baby.
  • If both the mother and the infant/fetus have adverse events, separate reports should be submitted for each patient.

A1:     Patient Identifier
Do not use the patient's name or social security number. You should provide the patient's initials, patient number, or some other type of identifier that will allow you, the reporter, to readily locate the case if you are contacted for more information.

The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law.The FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.

If no patient was involved, as may be the case with a problem quality problem or a product use error, enter ‘none’.

A2 :    Age at Time of Event or Date of Birth
Provide the most precise information available. Enter the patient's birth date, if known, or the patient's age at the time of event onset. For age, indicate time units used (e.g., years, months, days).

  • If the patient is 3 years or older, use years (e.g., 4 years)
  • If the patient is less than 3 years old, use months (e.g., 24 months)
  • If the patient is less than 1 month old, use days (e.g., 5 days)
  • Provide the best estimate if exact age is unknown

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A3:    Sex
Enter the patient's gender. If the adverse event is a congenital anomaly/birth defect, report the sex of the child.
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A4 :    Weight
Indicate whether the weight is in pounds (lb) or kilograms (kg). Make a best estimate if exact weight is unknown.
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SECTION B: ADVERSE EVENT, PRODUCT PROBLEM OR ERROR

B1 :     Adverse Event and/or Product Problem, Product Use Error, Problem with Different Manufacturer of Same Medicine
Choose the appropriate box(es). If a product problem may have caused or contributed to the adverse event, check both boxes.

Adverse event: Any incident where the use of a medication (drug or biologic), at any dose, human cell/tissue product, blood product, a medical device (including in vitro diagnostics) or a special nutritional product (e.g., dietary supplement, infant formula or medical food) is suspected to have resulted in an adverse outcome in a patient.

To report, it is not necessary to be certain of a cause/effect relationship between the adverse event and the use of the medical product(s) in question. Suspicion of an association is sufficient reason to report. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event. For whole blood and blood components, adverse events can include adverse outcomes in a blood donor or recipient.  

Please limit your submissions to those events that are serious. An event is classified as serious when the patient outcome attributed to the adverse event is:

  • Death
  • Life-threatening
  • Hospitalization (initial or prolonged)
  • Disability or Permanent Damage
  • Congenital anomaly/Birth Defect
  • Required medical or surgical intervention to prevent permanent impairment or damage (Devices)
  • Other Serious (Important Medical Events)

Please see instructions for block B2 for further information on each of these criteria.

Product problem (e.g., defects/malfunctions): Any report regarding the quality, performance, or safety of any medication, medical device or special nutritional product. In addition, please select this category when reporting device malfunctions that could lead to a death or serious injury if the malfunction were to recur.

Product problems include, but are not limited to, such concerns as:

  • Suspected counterfeit product
  • Suspected contamination
  • Questionable stability
  • Physical defects (such as color, powdering, chipped)
  • Defective components for both devices or drug products (such as a patch that is hard to peel the backing off)
  • Product confusion (caused by name, labeling, design or packaging)
  • Suspected super potent or subpotent medication
  • Labeling problems caused by printing errors/omissions
  • Failure to meet performance specifications (including labeling claims) or failure to perform as intended - medical devices

Product Use Error:  

Medical Product Use Error: Any report of a product error regardless of patient involvement or outcome. Also report circumstances or events that have the capacity to cause error (e.g., similar product appearance, similar packaging and labeling, sound-alike/look-alike names, etc.).

Product use errors can and do originate in all stages of the medication use system, which includes selecting and procuring drugs, prescribing, preparing and dispensing, administering and monitoring. A product use error is defined as “any preventable event that may cause or lead to inappropriate medical product use or patient harm while the product is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use.”

Medical Device Use Error:  Health care professionals, other caregivers and patients sometimes make errors when using medical devices that can unintentionally cause harm to patients or to themselves. These problems can arise due to problems with the design of the medical device or the manner in which the device is used. Sometimes use errors are noticed and corrected before they can do harm (known as a “close call”). 

Please report device use errors regardless of patient involvement or outcome. Also report circumstances of use or device interactions that could cause or lead to use errors. Medical device use errors can occur for reasons that include the following:

  • Device use is inconsistent with the user’s expectations or intuition
  • Device use requires physical, perceptual, or cognitive abilities that exceed those of the user
  • Devices are used in ways that were not anticipated by the manufacturer
  •  The device’s labeling or packaging is confusing or inadequate
  • The environment adversely affects or influences device use

Problem with Different Manufacturer of Same Medicine:  Any incident, to include, but not limited to, differences in previous therapeutic response, suspected to have resulted from a switch, or change, from one manufacturer to another manufacturer of the same medicine or drug product. This could be changes from a brand name drug product to a generic manufacturer's same product, or from a generic manufacturer's product to the same product as supplied by a different generic manufacturer, or from a generic manufacturer's product to a brand name manufacturer of the same product. 

In order to fully evaluate the incident, please include in Section B5, if available, specific information relative to the switch between different manufacturers of the same medicine, to include, but not limited to, the names of the manufacturers, length of treatment on each manufacturer's product, product strength, and any relevant clinical data including but not limited to the expected clinical response and how it was changed. If you have returned to your prior medication, please note if the prior therapeutic response has returned.
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B2 :    Outcomes Attributed to Adverse Event: Indicate all that apply to the reported event:

Death: Check only if you suspect that the death was anoutcome of the adverse event, and include the date if known.
Do not check if:

  • The patient died while using a medical product, but there was no suspected association between the death and the use of the product
  • A fetus is aborted because of a congenital anomaly (birth defect), or is miscarried

Life-threatening: Check if you suspect that:

  • The patient was at substantial risk of dying at the time of the adverse event, or
  • Use or continued use of the device or other medical product might have resulted in the death of the patient

Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Do not check if:

  • A patient in the hospital received a medical product and subsequently developed an otherwise non-serious adverse event, unless the adverse event prolonged the hospital stay

Do check if:

  • A patient is admitted to the hospital for one or more days, even if released on the same day
  • An emergency room visit results in admission to the hospital

Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes [e.g., life-threatening;required intervention to prevent permanent impairment or damage; other serious (medically important event)]

Disability or Permanent Damage: Check if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions. Such would be the case if the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.

Congenital Anomaly/Birth Defect: Check if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.

Required Intervention to Prevent Permanent Impairment or Damage ( for Medical Devices): Check if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.

Other Serious (Important Medical Events):
Check when the event does not fit the other outcomes, but the event could have jeopardized the patient and could have required medical or surgical intervention (treatment) to prevent one of the other outcomes.  Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures / convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.
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B3 :    Date of Event
Provide the actual or best estimate of the date of first onset of the adverse event. If day is unknown, month and year are acceptable. If day and month are unknown, year is acceptable.

  • When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child
  • When a fetus is aborted because of a congenital anomaly, or is miscarried, the event onset date is the date pregnancy is terminated

If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.
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B4 :    Date of this Report
The date the report is filled out.
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B5 :    Describe Event, Problem or Product Use Error
For an adverse event:

Describe the event in detail, including a description of what happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.). If available and if relevant, include synopses of any office visit notes or the hospital discharge summary.
To save time and space (and if permitted by your institution), please attach copies of these records with any confidential information deleted. Do not identify any patient, physician, or institution by name. The reporter's identity should be provided in full in section G.

Information as to any environmental conditions that may have influenced the event should be included, particularly when (but not exclusive to) reporting about a device.

  • Results of relevant tests and laboratory data should be entered in block B6. (See instructions for B6).
  • Preexisting medical conditions and other relevant history belong in block B7. Be as complete as possible, including time courses for preexisting diagnoses (see instructions for B7).

If it is determined that reuse of a medical device labeled for single use might have caused or contributed to an adverse patient outcome, please report in block B5 the facts of the incident and the perceived contribution of reuse to the occurrence.

If the adverse event involves a human cell, tissue, and cellular and tissue-based product (HCT/Ps), include the following information:  diagnosis/condition for which the HCTP was implanted, the type of surgical procedure and anatomical site of implantation, and the date of onset of symptoms.

For adverse events occurring in donors of whole blood or blood components, please indicate that the adverse event occurred in a donor and the procedure for donation (e.g., apheresis, phlebotomy).

For a product problem: Describe the problem (quality, performance, or safety concern) in sufficient detail so that the circumstances surrounding the defect or malfunction of the medical product can be understood.

  • If available, the results of any evaluation of a malfunctioning device and, if known, any relevant maintenance/service information should be included in this section
  • For a medication, food, cosmetic  or special nutritional product problem, please indicate if you have retained a sample that would be available to FDA

For a product use error: (see B1 above): Describe the sequence of events leading up to the error in sufficient detail so that the circumstances surrounding the error can be understood. 

For Medication Use Errors: Include a description of the error, the type of staff involved, the work environment in which the error occurred, indicate causes or contributing factors to the error, location of the error, names of the products involved (including the trade (proprietary) and established (proper) name, manufacturer, dosage form, strength, concentration, and type and size of container.

For Medical Device Use Errors: Include a description of the device use error, the type of staff involved, the work environment in which the error occurred, and the circumstances or events that led to or contributed to the use errors.  Medical device use errors can occur for reasons that include the following:

  • Device use is inconsistent with the user’s expectations or intuition,
  • Device use requires physical, perceptual, or cognitive abilities that exceed those of the user,
  • Devices are used in ways that were not anticipated by the manufacturer,
  • The device’s labeling or packaging is confusing or inadequate,
  • The environment adversely affects or influences device use

For a problem with a different manufacturer of the same medicine (see B1 above):
Please include specific information relative to the switch between different manufacturers of the same medicine, to include, but not limited to, the names of each manufacturer, length of treatment on each manufacturer's product, product strength, dosing regimen and any relevant clinical data.
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B6:    Relevant Tests/Laboratory Data, Including Dates
Please provide all appropriate information, including relevant negative test and laboratory findings, in order to most completely convey how the medical work-up/ assessment led to strong consideration of medical product-induced disease as etiology for clinical status, as other differential diagnostic considerations were being eliminated.

Please include:

  • Any relevant baseline laboratory data prior to the administration or use of the medical product
  • All laboratory data used in diagnosing the event
  • Any available laboratory data/engineering analyses (for devices) that provide further information on the course of the event

If available, please include:

  • Any pre- and post-event medication levels and dates (if applicable)
  • Synopses of any relevant autopsy, pathology, engineering, or lab reports

If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. Do not identify any patient, physician or institution by name. The initial reporter's identity should be provided in full in section G.
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B7:    Other Relevant History, Including Preexisting Medical Conditions
Knowledge of other risk factors can help in the evaluation of a reported adverse event. For example, if available, provide information on:

  • Other known conditions in the patient, e.g.,
    • Hypertension (high blood pressure)
    • Diabetes mellitus
    • liver or kidney problems
    •  Pre-existing infection (in recipients of human and cell and tissue products)
  • Significant history
    • Race
    • Allergies 
    • Pregnancy history
    • Smoking and alcohol use, drug abuse
    • Setting

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 SECTION C: PRODUCT AVAILABILITY

Product available for evaluation? To evaluate a reported problem with a medical product, it is often critical to be able to examine the product. Please indicate whether the product is available for evaluation.
Also indicate if the product was returned to the manufacturer and, if so, the date of the return.

Do not send the product to FDA.
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SECTION D: SUSPECT PRODUCTS(S)
Please complete Section D if the event, problem or error involved one of the following products:

  • Prescription or over-the-counter medication
  • Biologic product, such as human cells and tissues used for transplantation (e.g. tendons, ligaments and bone) and gene therapy
  • Nutrition product, such as a vitamin or mineral, herbal remedy, infant formula, or medical food or beverage
  • Cosmetic product
  • Foods, including beverages (especially serious food allergens)

For adverse event reporting:

A suspect product is one that you suspect is associated with the adverse event. In section F enter other concomitant medical products (drugs, biologics including HCT/Ps, medical devices, etc.) that the patient was using at the time of the event but which you do not think were involved in the event.

Up to two (2) suspect products may be reported on one form (#1 = first suspect product, #2 = second suspect product). Attach an additional form if more than two suspect products were associated with the reported adverse event.

For product quality problem reporting:

A suspect product is the product that is the subject of the report. A separate form should be submitted for each individual product problem report. Identification of the labeler/distributor and pharmaceutical manufacturer , the labeled strength,  the NDC number and when appropriate, the lot number of the product is critical in FDA evaluation of product quality problems  for prescription or non-prescription products.

This section may also be used to report on special nutritional products (e.g., dietary supplements, infant formula or medical foods), cosmetics, human cells, tissues, or cellular and tissue-based products (HCT/Ps) or food (especially reports of serious food allergens).
If reporting on a special nutritional or a drug product quality problem, please attach labeling/ packaging if available.
If reporting on a special nutritional only, please provide directions for use as listed on the product labeling.
D1:    Name, Strength, Manufacturer
Use the trade/brand name. If the trade/brand name is not known or if there is no trade/brand name, use the generic product name and the name of the manufacturer or labeler. When reporting a product quality problem or therapeutic failure for a generic drug product, it is essential in evaluating the report that the name of the manufacturer, the strength of the drug, the NDC number and the lot number be provided. These names are usually found on the product packaging or labeling. If not located, please consider speaking with the pharmacist or pharmacy that dispensed the product to obtain that information.
Strength is the amount in each tablet or capsule, the concentration of an injectable, etc. (such as “10mg”, “100 units/cc”, etc.).
For human cells, tissues, and cellular and tissue-based products (HCT/Ps), please provide the common name of the HCT/P. If the HCT/P has a proprietary or trade name, you can provide that in addition to the common name (e.g., Brand X bone chips).  Examples: Achilles tendon, Iliac crest bone or Islet cells.
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D2:    Dose or Amount, Frequency, Route
Describe how the product was used by the patient (e.g., 500 mg QID orally or 10 mg every other day IV). For reports involving overdoses, the amount of product used in the overdose should be listed, not the prescribed amount.
See APPENDIX I for list of Routes of Administration
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D3:    Dates of Use
Provide the date administration was started (or best estimate) and the date stopped (or best estimate). If no dates are known, an estimated duration is acceptable (e.g., 2 years) or if therapy was less than one day, then duration is appropriate (e.g., 1 dose or 1 hour for an IV).
For human cells, tissues, and cellular and tissue-based products, provide the date of transplant and if applicable, the date of explantation.
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D4:    Diagnosis or Reason for Use (Indication)
Provide the reason or indication for which the product was prescribed or used in this particular patient.

D5:    Event Abated After Use Stopped or Dose Reduced
If available, this information is particularly useful in the evaluation of a suspected adverse event. In addition to checking the appropriate box, please provide supporting lab tests and dates, if available, in block B6.
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D6:    Lot # 
If known, include the lot number(s) with all product quality problem reports, or any adverse event report with a biologic, or medication.
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D7:    Expiration Date 
Please include if available.
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D8:    Event Reappeared After Reintroduction
This information is particularly useful in the evaluation of a suspected adverse event. In addition to checking the appropriate box, please provide a description of what happened when the drug was stopped and then restarted in block B5, and any supporting lab tests and dates in block B6.
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D9:    NDC # or Unique ID
The national drug code (NDC #) is found on the original product label and/or packaging, but is usually not found on dispensed pharmacy prescriptions. NDC numbers are especially useful to the FDA in investigating drug product quality problems. Please include any zeros and dashes in the NDC # as they appear on the label and/or packaging.

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) must have a Unique ID number to track the product.  For reports involving HCT/Ps, this unique ID should be provided in this box.
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SECTION E: SUSPECT MEDICAL DEVICE
Please complete Section E if the event, problem or error involved one of the following medical devices:

  • A piece of medical equipment, tool or test
  • A health-related kit, such as a blood glucose monitoring kit
  • An implanted device, such as a breast implant, pacemaker or catheter
  • A consumer health product, such as a contact lens, hearing aid, or breast pump

The suspect medical device is 1) the device that might have caused or contributed to the adverse event or 2) the device that malfunctioned.
In section F, report other concomitant medical products (drugs, biologics including HCT/Ps, medical devices, etc.) that the patient was using at the time of the event but which you think were not involved in the event.

If more than one suspect medical device was involved in the event, prepare a complete FDA Form 3500 that identifies one device and attach a separate Form 3500, with only section E filled in, for each additional device.
If the suspect medical device is a single use device that has been reprocessed, then the reprocessor should be identified as the device manufacturer.

E1:    Brand Name
The trade or proprietary name of the suspect medical device as used in product labeling or in the catalog (e.g., Flo-Easy Catheter, Reliable Heart Pacemaker, etc.). This information might 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. Reprocessed single use devices may bear the Original Equipment Manufacturer (OEM) brand name. If the suspect device is a reprocessed single-use device enter "NA".
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E2a:    Common Device Name
The generic or common name of the suspect medical device or a generally descriptive name (e.g., urological catheter, heart pacemaker, patient restraint). Please do not use broad generic terms such as "catheter", "valve", "screw", etc.

E2b: Procode

The FDA classification product code (a code that consists of three alpha characters) that corresponds to the common device name can be entered here if it is known.
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E3:    Manufacturer Name, City and State
If available, list the full name, city and state of the manufacturer of the suspected medical device. If the answer in Block E8 is "yes", then enter the name, city and state of the reprocessor.
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E4:    Model #, Catalog #, Serial #, Lot #, Expiration date, Unique Identifier (UDI) #
If available, provide all identification numbers associated with the suspect medical device exactly as they appear on the device or device labeling. This includes spaces, hyphens, etc.

Model #: The exact model number found on the device label or accompanying packaging.
Catalog #: The exact number as it appears in the manufacturer's catalog, device labeling, or accompanying packaging.
Serial #: This number can be found on the device, its label, or accompanying packaging; it is assigned by the manufacturer, and should be specific to each device.
Lot #: This number can be found on the label or packaging material.
Expiration date (mm/dd/yyyy): If available, this date can often be found on the device itself or printed on the accompanying packaging.
Unique Identifier (UDI) #: This number can be found on the device, its label, or accompanying packaging.  The number is located below the barcode and begins with one of the following three elements:

    • (01) 
    • +
    •  =

Record all numbers, letters, parentheses, and symbols included in the UDI #.

For more information regarding the UDI #, refer to the UDI webpage http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm or contact the UDID HelpDesk at UDIDSupport@fda.hhs.gov
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E5: Operator of Device
Indicate the type (not the name) of person operating or using the suspect medical device on the patient at the time of the event as follows:

  • Health professional = physician, nurse, respiratory therapist, etc.
  • Lay user/patient = person being treated, parent/spouse/friend of the patient, etc.
  • Other = nurses aide, orderly, etc.

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E6:   If implanted, give date (mm/dd/yyyy)
For medical devices that are implanted in the patient, provide the implant date or your best estimate.  If day is unknown, month and year are acceptable. If month and day are unknown, year is acceptable.
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 E7:   If explanted, give date (mm/dd/yyyy)
If an implanted device was removed from the patient, provide the explantation date or your best estimate. If day is unknown, month and year are acceptable. If month and day are unknown, year is acceptable.
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 E8:   Is this a Single-use Device that was Reprocessed and Reused on a Patient?
Indicate "Yes" or "No".
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 E9:  If Yes to Item No. 8, Enter Name and Address of Reprocessor:
Enter the name and address of the reprocessor of the single-use device. A firm that reprocesses single-use devices for reuse in humans considered to be the manufacturer of the reprocessed device.
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 SECTION F: OTHER (CONCOMITANT) MEDICAL PRODUCTS
Information on the use of concomitant medical products can frequently provide insight into previously unknown interactions between products, or provide an alternative explanation for the observed adverse event. Please list product names and therapy dates for any other medical products (drugs, biologics including HCT/Ps, medical devices, etc.) that the patient was using at the time of the event. Do not include products used to treat the patient after the event.
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SECTION G: INITIAL REPORTER
FDA recognizes that confidentiality is an important concern in the context of adverse event reporting. The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law. However, to allow for timely follow-up in serious cases, the reporter's identity may be shared with the manufacturer unless specifically requested otherwise in block G5. The FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.

G1:   Name, Address, Phone #, Email
Please provide the name, mailing address, phone number and E-mail address of the person who can be contacted to provide information on the event if follow-up is necessary. Providing a fax number would be helpful, if available. This person will also receive an acknowledgment letter by U.S. mail or a return email message from FDA to confirm receipt of the report.

For voluntary reporters from a non-U.S. country, please indicate country name and postal code.
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G2:   Health Professional?
Please indicate whether you are a health professional (e.g. physician, pharmacist, nurse, etc.) or not. If you are not a health professional, please enter “NA” in block G3.
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G3:   Occupation:
Please indicate your occupation (particularly type of health professional), and include specialty, if appropriate. If you are not a health professional, please enter “NA”.
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G4:    Also Reported to:
Please indicate whether you have also notified or submitted a copy of this report to the manufacturer and/or distributor of the product, or, in the case of medical device reports only, to the user facility (institution) in which the event occurred. This information helps to link your report on this event to the reports filed by other sources.
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G5:   Release of reporter's identify to the manufacturer
In the case of a serious adverse event, FDA might provide the name, address and phone number of the reporter denoted in block G1 to the manufacturer of the suspect product. If you do not want your identity released to the manufacturer, please put an X in this box.
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APPENDIX I
ROUTES OFADMINISTRATION: ICH LIST AND CODES


Description

ICH-M2 Numeric Codes

Auricular (otic)

001

Buccal

002

Cutaneous

003

Dental     

004

Endocervical

005

Endosinusial

006

Endotracheal

007

Epidural

008

Extra-amniotic

009

Hemodialysis

010

Intra corpus cavernosum

011

Intra-amniotic

012

Intra-arterial

013

Intra-articular

014

Intra-uterine

015

Intracardiac

016

Intracavernous

017

Intracerebral

018

Intracervical

019

Intracisternal

020

Intracorneal

021

Intracoronary

022

Intradermal

023

Intradiscal (intraspinal)

024

Intrahepatic

025

Intralesional

026

Intralymphatic

027

Intramedullar (bone marrow)

028

Intrameningeal

029

Intramuscular

030

Intraocular

031

Intrapericardial

032

Intraperitoneal

033

Intrapleural

034

Intrasynovial

035

Intratumor

036

Intrathecal

037

Intrathoracic

038

Intratracheal

039

Intravenous bolus

040

Intravenous drip

041

Intravenous(not otherwise specified)

042

Intravesical

043

Iontophoresis

044

Occlusive dressing technique

045

Ophthalmic

046

Oral

047

Oropharingeal

048

Other

049

Parenteral

050

Periarticular

051

Perineural

052

Rectal

053

Respiratory (inhalation)

054

Retrobulbar

055

Sunconjunctival

056

Subcutaneous

057

Subdermal

058

Sublingual

059

Topical

060

Transdermal

061

Transmammary

062

Transplacental

063

Unknown

064

Urethral

065

Vaginal

066