§ 804.28 - Reporting form.

(a) Each distributor that submits a report on an MDR reportable event shall complete and submit the applicable portions of FDA form 3500A in so far as the information is known or should be known to the distributor, and submit it to FDA, and to the manufacturer as required by § 804.25.

(b) Each distributor shall submit the information requested on FDA form 3500A, including:

(1) Identification of the source of the report.

(i) Type of source that reported the event to thedistributor (e.g., lay user owner; lay user lessee, hospital, nursing home, outpatient diagnostic facility, outpatient treatment facility, ambulatory surgical facility);

(ii) Distributor report number;

(iii) Name, address, and telephone number of the reporting distributor and the source that reported the event to the distributor; and

(iv) Name of the manufacturer of the device.

(2) Date information.

(i) The date of the occurrence of the event;

(ii) The date the source that reported the event to the distributor became aware of the event;

(iii) The date the event was reported to the manufacturer and/or FDA; and

(iv) The date of this report.

(3) The type of MDR reportable event, e.g., death, serious illness, serious injury, or malfunction, and whether an imminent hazard was involved;

(4) Patient information including age, sex, diagnosis, and medical status immediately prior to the event and after the event;

(5) Device information including brand and labeled name, generic name, model number or catalog number or other identifying numbers, serial number or lot number, purchase date, expected shelf life/expiration date (if applicable), whether the device was labeled for single use, and date of implant (if applicable);

(6) Maintenance/service information data including the last date of service performed on the device, where service was performed, whether service documentation is available, and whether service was in accordance with the service schedule;

(7) Whether the device is available for evaluation and, if not, the disposition of the device;

(8) Description of the event.

(i) Who was operating or using the device when the eventoccurred;

(ii) Whether the device was being used as labeled or as otherwise intended;

(iii) The location of the event;

(iv) Whether there was multi-patient involvement, and if so, how many patients were involved;

(v) A list of any other devices whose performance may have contributed to the event and their manufacturers, and the results of any analysis or evaluation with respect to such device (or a statement of why no analysis or evaluation was performed); and

(vi) A complete description of the event including, but not limited to, what happened, how the device was involved, the nature of the problem, patient followup/treatment required, and any environmental conditions that may have influenced the event.

(9) The results of any analysis of the device and the event, including:

(i) The method of evaluation or an explanation of why no evaluation was necessary or possible;

(ii) The results and conclusions of the evaluation;

(iii) The corrective actions taken; and

(iv) The degree of certainty concerning whether the device caused or contributed to the reported event;

(10) The name, title, address, telephone number, and signature of the person who prepared the report.