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.

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 codes to describe the patient’s condition during the reportable event. Use device codes to describe the nature of the device failure or problem. 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.

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

Uploaded on May 23, 2001

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