Instructions for Completing Form FDA 3500
- Information for Consumers, Patients and Caregivers
- General Instructions for completing FDA Form 3500
- Section A: Patient Information
- Section B: Adverse Event or Product Problem
- Section C: Product Availability
- Section D: Suspect Products
- Section E: Suspect Medical Device
- Section F: Other (Concomitant) Medical Products
- Section G: Reporter
- Questions About Specific Medical Products
Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for:
- Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
- Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
- Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.
- Combination products such as pre-filled drug syringe, auto-injectors, metered-dose inhalers, contact lens coated with a drug and nasal-spray.
- Cosmetics such as moisturizers, shampoos, conditioners, hair dyes and tattoos.
- Cannabinoid hemp products such as products containing CBD.
Adverse events involving vaccines should be reported to the Vaccine Adverse Event Reporting System (VAERS). For additional information or assistance with filing a VAERS report, call: 1-800-822-7967.
Report problems or adverse health events and tobacco product problems that include problems with e-cigarettes (also known as “vapes”), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus to the Safety Reporting Portal.
Animal Drug, Device, Pet Food and Livestock Feed Problems: Please visit www.fda.gov/vetproductreporting.
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.
Information for Consumers, Patients and Caregivers:
FDA has 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 Form FDA 3500 to your health professional (e.g., health care provider, nurse 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.
Instructions for Voluntary Reporting by Health Professionals, Consumers, and Patients
Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Section D, Suspect product[s], should be used to report cosmetics as well as drugs and 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), cannabinoid or hemp products (such as products containing CBD).
A1: Patient Identifier 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 Form FDA 3500 for one patient and indicate the number of patients in block B5 (Describe Event, Problem or Product Use Error). Then attach additional copies of Form FDA 3500 with only Section A and blocks B2, B5, B6, B7, and F filled in for each additional patient. A1: Patient Identifier A2 : Age or Date of Birth A3: Sex A4 : Weight Return to Top of Section
A2: Age or Date of Birth
A3: Sex
A4: Weight
A5: Ethnicity
A6: Race
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:
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’.
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).
Enter the patient’s sex at birth.
Indicate whether the weight is in pounds (lb) or kilograms (kg). Make a best estimate if exact weight is unknown.
A5: Race and/or Ethnicity (Select all that apply).
Indicate the ethnicity and/or race of the patient as reported by the patient. You may choose multiple responses for race/ethnicity. Please do NOT make a best guess.
B1: Type of Report B1: Type of Report 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: Please see instructions for block B2 for further information on each of these criteria. Product Use/Medication Error: 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: 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: 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. B2 : Outcome Attributed to Adverse Event: Indicate all that apply to the reported event: Do not check if: 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: Do check if: 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)] Life-threatening: Check if you suspect that: 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. Required Intervention to Prevent Permanent Impairment or Damage: 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. Congenital Anomaly/Birth Defects: 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. Other Serious or 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 bronchospasm (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. B3 : Date of Event If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5. B4 : Date of this Report B5 : Describe Event, Problem or Product Use/Medication Error 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. 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 Cosmetic Products we encourage to provide other available and relevant information pertinent to this adverse event such as: 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. 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 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: 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. B6: Relevant Tests/Laboratory Data, Including Dates (dd/mmm/yyyy) Please include: If available, please include: 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. Use the Additional comments box to include any other information. B7: Other Relevant History, Including Preexisting Medical Conditions
B2: Outcome Attributed to Adverse Event
B3: Date of Event
B4: Date of this Report
B5: Describe Event, Problem or Product Use Error/Medication Error
B6: Relevant Tests/Laboratory Data, Including Dates
B7: Other Relevant History, Including Preexisting Medical Conditions
Choose the appropriate box. Both boxes should be checked if a product problem may have caused or contributed to the adverse event.
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.).
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.
Death: Check only if you suspect that the death was an outcome of the adverse event, and include the date if known.
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.
The date the report is filled out.
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.
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.
Knowledge of other risk factors can help in the evaluation of a reported adverse event. For example, if available, provide information on:
C1: Product Available for Evaluation? C1: 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. C2: Do You Have a Picture of the Product?
C2: Do You Have a Picture of the Product?
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
Do not send the product to FDA.
D1: Name, Strength, Manufacturer/Compounder (from product label) Please complete Section D if the event, problem or error involved one of the following products: 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 cosmetics, human cells, tissues, or cellular and tissue-based products (HCT/Ps) or food (especially reports of serious food allergens). If reporting on a drug product quality problem, please attach labeling/ packaging if available. If reporting only, please provide directions for use as listed on the product labeling. D1: Name and Strength, Manufacturer/Compounder, NDC# or Unique ID and Lot #: 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. 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. Strength is the amount in each tablet or capsule, the concentration of an injectable, etc. (such as “10mg”, “100 units/cc”, etc.). 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. Lot # 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. D3: Treatment Dates/Therapy Dates: 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. D4: Diagnosis for Use (Indication): Provide the reason or indication for which the product was prescribed or used in this particular patient. D5: Product Type: Is the product over-the-counter, compounded, generic or a biosimilar, cosmetics for professional use, cosmetics sold on a retail basis -please check the option that best fits this medical product. D6: Expiration Date: Expiration date: Please include if available. For cosmetic products, if available, please include Best by/Use by date. D7: 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. D8: Event Reappeared After Reintroduction?
D2: Dose or Amount, Frequency, Route
D3: Treatment Dates/Therapy Dates
D4: Diagnosis for Use (Indication)
D5: Product Type
D6: Expiration Date
D7: Event Abated After Use Stopped or Dose Reduced?
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.
E1: Brand Name Please complete Section E if the event, problem or error involved one of the following medical devices: The suspect medical device is 1) the device that might have caused or contributed to the adverse event or 2) the device that malfunctioned. If more than one suspect medical device was involved in the event, prepare a complete Form FDA 3500 that identifies one device and attach a separate Form FDA 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". E2a: 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. E2b: 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. 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. E4: Model #, Lot #, Catalog #, Expiration Date, Serial #, Unique Device 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. Please record all numbers, letters, parentheses, and symbols included in the UDI #. Complete information will enable effective parsing of the UDI into its components for use with important public health needs. Please submit all applicable UDIs for a given adverse event submission. For more information regarding the UDI #, refer to the UDI webpage, or https://www.fda.gov/medical-devices/device-advice- comprehensive-regulatory-assistance/unique-device-identification-system-udi-system or contact the FDA UDI Helpdesk at https://www.fda.gov/medical-devices/unique-device-identificationsystem-udi-system/fda-udi-help-desk or by emailing 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: E6a: If Implanted, Give Date (dd/mmm/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. E6b: If Explanted, Give Date (dd/mmm/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. E7a: Is this a Single-use Device that was Reprocessed and Reused on a Patient?: Indicate "Yes" or "No". E7b: If Yes to Item No. E7a, Enter Name and Address of Reprocessor: Enter the name and address of the reprocessor of the single-use device. Any entity that reprocesses single-use devices for reuse in humans is the manufacturer of the reprocessed single-use device. E8: Was This Device Ever Serviced by a Third Party Servicer? Indicate “Yes”, “No” or “Unknown.”
E2a: Common Device Name
E2b: Procode
E3: Manufacturer Name, City and State
E4: Model #, Lot #, Catalog #, Expiration Date, Serial #,Unique Device Identifier (UDI) #
E5: Operator of Device
E6a: If Implanted, Give Date
E6b: If Explanted, Give Date
E7a: Is this a Single-use Device that was Reprocessed and Reused on a Patient?
E7b: If Yes to Item 7a, Enter Name and Address of Reprocessor
E8: Was This Device Ever Serviced by a Third Party Servicer?
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.
GUDIDSupport@fda.hhs.gov
F1: Product Names and Therapy Dates F1: Product Names and Therapy Dates (dd/mmm/yyyy): 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.
G1: Name, Address, Phone #, Email 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 if the information is provided. G2: Health Professional?: Check "Yes" if you are a health professional (e.g. physician, pharmacist, nurse, etc.) and "No" if you are not. G3: Occupation: Please indicate your occupation (particularly type of health professional), and include specialty, if appropriate. If you are not a health professional, select Non-Health Professional. 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. 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.
G2: Health Professional?
G3: Occupation
G4: Also Reported to:
G5: If you do NOT want your identity disclosed to the manufacturer
For voluntary reporters from a non-U.S. country, please indicate country name and postal code.
For questions about specific products:
Product Type | E-mail Inquiries | Telephone Inquiries |
| Drugs | Division of Drug Information 1-888-463-6332 1-301-796-3400 | |
| Special Nutritional Products (dietary supplements, infant formulas, medical foods), Cosmetics and Foods/Beverages | Food, Nutrition, and Cosmetics Questions & Answers Email: Consumer@fda.gov | 1-888-723-3366 |
| Medical Devices | Center for Devices and Radiological Health, Division of Industry and Consumer Education (DICE) Email: DICE@fda.hhs.gov | 1-800-638-2041 |
| Vaccines, Blood Products, Other Biologics | Center for Biologics Evaluation and Research, Email: ocod@fda.hhs.gov | 1-800-835-4709 |
| Tobacco Products | Center for Tobacco Products General Inquiries Email: AskCTP@fda.hhs.gov | 1-877-CTP-1373 or 1-301-796-9200 |
| Animal Drug, Device, Pet Food and Livestock Feed Products | Center for Veterinary Medicine Email: AskCVM@fda.hhs.gov | 1-888-FDA-VETS or 1-888-332-8387 |