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U.S. Department of Health and Human Services

Medical Devices

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MEDWATCH Medical Device Reporting Code Instructions

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FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

 

 

 

 

 

MEDWATCH MEDICAL DEVICE REPORTING CODE
INSTRUCTIONS

 

 

 

 

 

 

 

APRIL 4, 2001

 

 


MEDWATCH MEDICAL DEVICE REPORTING CODE
INSTRUCTIONS

INTRODUCTION

The MedWatch Medical Device Reporting Code Manual contains codes to describe reportable device adverse event information. The codes are used when completing the back of MedWatch Form 3500A. Information regarding obtaining and submitting Form 3500A is found in Appendix A.

User facilities and importers provide patient and device problem codes in Block F10, Event problem codes. Device manufacturers provide codes in Block H3 Device evaluation information, Block H6 Evaluation codes, and Block H10 Additional manufacturer narrative. Detailed instructions are provided below. Patient and device evaluation codes are listed alphabetically in Appendix B. A preview of the enhanced CDRH Event Problem Codes and a link to the new CDRH Event Problem Code website is available online. CDRH will begin accepting the updated codes on July 1, 2009. All inactivated and retired codes will no longer be accepted as valid Event Problem Codes on January 1, 2010.

You may use more than three codes to describe a patient or device problem, evaluation method or results, or conclusion. If more than three codes are reported in these blocks, attach a separate page to Form 3500A and reference your report number and Block # (i.e., F10, H6, etc.) for the codes reported.

1. BLOCK F10 ON FORM 3500A, EVENT PROBLEM CODES (21 CFR 803.20, 803.32, 803.42, 803.52)
Use patient problem codes to indicate the effects that an event may have had on the patient, including signs, symptoms, syndromes, or diagnosis and device codes to describe device failures or issues related to the device that are encountered during the event. You should report at least one patient code and one device code.

A numerical list of patient and device codes is found in Appendix C. A preview of the enhanced CDRH Event Problem Codes and a link to the new CDRH Event Problem Code website is available online.

2. BLOCKS H3 AND H6 ON FORM 3500A, DEVICE MANUFACTURER CODES (21 CFR 803.52)

A. Block H3, Device Evaluated by Manufacturer Codes
If you will not perform an evaluation of the returned device, select the "no" box and enter one of the codes below.

01 Device received in a condition which made analysis impossible
02 Device evaluation anticipated, but not yet begun
03 Device not made by company
04 Device problem already known, no evaluation necessary
81 Other (code unspecified, describe in H10)

B. Block H6, Evaluation Codes

  1. You may use as many codes as necessary to accurately reflect the evaluation source and method results and conclusions. This applies to all codes entered in Block H6. The evaluation method codes capture two items – the source of the device that was evaluated and the type of evaluation performed. Use at least one code from each of the two lists immediately below.

    Source of Evaluated Device
    10 Actual device involved in incident was evaluated
    11 A device from same lot of the actual device involved in incident was evaluated
    12 Device from reserve sample evaluated
    13 Device from controlled/non-released inventory evaluated

    Type of Evaluation Performed
    20 Device evaluated with respect to operational environment
    21 Computer hardware performance tests conducted
    22 Computer software performance tests conducted
    23 Electrical tests performed
    25 Electrical tests of all specifications performed
    26 Mechanical tests performed
    27 Mechanical tests, dynamic – fatigue test
    28 Mechanical tests, static – tension or compression failure
    30 Mechanical tests of all specifications performed
    31 Performance tests performed
    33 Performance tests of all specifications performed
    34 Performed test to determine if incident was the result of interaction with another device(s)
    35 User-device interface test performed
    36 Analysis of labeling performed
    37 Photographic images made during evaluation
    38 Visual examination
    39 Chemical tests (e.g., corrosion, reaction)
    82 Environmental tests; temperature, humidity and vibration
    83 Pathological evaluation of returned device (i.e., vascular grafts, heart valves, etc.)
    84 Optical tests of all specifications performed
    86 Other (code unspecified, describe in H10)
  2. Use evaluation results codes to describe the results of your evaluation and analyses of the reported device problem(s). The evaluation results codes are found in Appendix D.

  3. Use conclusion codes below to describe your evaluation conclusions.

    40 Another device caused failure
    70 Device discarded – unable to follow-up
    71 Device evaluated and alleged failure could not be duplicated
    72 Device evaluated and alleged failure could not be duplicated – cause of event unknown
    41 Device failed during assembly
    64 Device failed during pre-test/pre-trial
    42 Device failed just prior to use
    43 Device failure directly cause event
    44 Device failure directly contributed to event
    45 Device failure indirectly caused event
    46 Device failure indirectly contributed to event
    47 Device failure occurred and was related to event
    48 Device failure occurred but not related to event
    49 Device failure related to maintenance
    61 Device failure related to user handling
    50 Device failure/lack of effectiveness related to patient condition
    51 Device maintenance contributed to event
    65 Device operated according to specifications
    63 Device repaired and returned
    52 Device was out of calibration
    53 Device was out of specification but this does not relate to event
    54 Device was out of specification in a manner that relates to event
    55 Intermittent failure directly caused event
    56 Intermittent failure directly contributed to event
    57 Labeling related
    67 No conclusion can be drawn
    78 No device failure
    74 No failure detected and product within specification
    75 No failure detected but product out of specification
    76 Operational context caused event
    77 Operational context contributed to event
    68 Other (code unspecified, describe in H10)
    58 Software/firmware caused event
    59 Software/firmware contributed to event
    88 This is a report of an accidental radiation occurrence (ARO)
    66 Unusual event
    79 User error caused event
    80 User error contributed to event
    62 User interface contributed to event
    60 User-interface caused event

3. BLOCKS H10 ON FORM 3500A, ADDITIONAL MANUFACTURER NARRATIVE (21 CFR 803.52)

Manufacturers reporting codes as "other" in Block H6 should fully describe the method, results and/or conclusions in Block H10. If any required information is not reported on the form 3500A, provide an explanation of what is not available, why, and detail the steps taken to obtain the missing information.

4. BLOCK H11 ON FORM 3500A, CORRECTED DATA (21 CFR 803.52)

Provide any missing or corrected codes from the user facility or importer (Block F10). For all codes, state whether the event described is addressed in the device labeling.

Dated 4/11/01