10421 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR MANUFACTURERS

10421.1 You must include the following information in your reports, if known or reasonably known to your patient information, you must submit the following:

1. (a) The patient's name or other identifier;
2. (b) The patient's age at the time of event, or date of birth;
3. (c) The patient's sex; and
4. (d) The patient's weight;

10421.2 For an adverse event or product problem, you must submit the following:

1. (a) Identification of the adverse event or product problem;
2. (b) The outcomes attributed to the adverse event (for example, death or serious injury). An outcome is considered a serious injury if it is:
3. (1) Life-threatening injury or illness;
4. (2) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or
5. (3) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function;
6. (4) The date of the event;
7. (5) The date of report by the initial reporter;
8. (6) A description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event;
9. (7) A description of relevant tests, including dates and laboratory data; and
10. (8) Any other relevant patient history including preexisting medical conditions.

10421.3 For device information, you must submit the following:- (a) The brand name;

- (b) The type of device;

- (c) Your name and address;

- (d) The operator of the device (health professional, patient, lay user, other);

- (e) The expiration date;

- (f) The model, catalog, serial, lot, or other identifying numbers;

- (g) The date of device implantation (month, day, and year);

- (h) The date of device explanation (month, day, and year);

- (i) Whether the device was available for evaluation, and whether the device was returned to you, and if so, the date it was returned to you; and

- (j) Concomitant medical products and therapy dates.10421.4 For initial reporter information, you must submit the following:- (a) Name, address, and phone number of the reporter who initially provided information to you, or to the user facility or importer;

- (b) Whether the initial reporter is a health professional;

- (c) Occupation; and

- (c) Whether the initial reporter also sent a copy of the report to the Department, if known.10421.5 When reporting information for all manufacturers, you must submit the following:- (a) Your reporting office's contact name and address and device manufacturing site;

- (b) Your telephone number;

- (c) Your report sources;

(d) The date received by you (month, day, and year);

(e) The type of report being submitted (for example, five (5) day, initial, or follow-up); and

(f) Your report number.

10421.6 For device manufacturer information, you must submit the following:

(a) The type of reportable event (death, serious injury, or malfunction);

(b) The type of follow-up report, if applicable (such as, correction or a response to the Department's request);

(d) If the device was returned to you and evaluated by you, you must include a summary of the evaluation. If you did not perform an evaluation, you must explain why you did not perform an evaluation;

(e) The device manufacture date (month, day, and year);

(f) Whether the device was labeled for single use;

(g) The evaluation codes (including event codes, method of evaluation, result, and conclusion codes);

(h) Whether remedial action was taken and the type of action;

(i) Whether the use of the device was initial, reuse, or unknown;

(j) Whether remedial action was reported as a removal or correction, and if it was, provide the correction or removal report number; and

(k) Your additional narrative; or

(l) Corrected data, including:

(1) Any information missing on the user facility report or importer report, including any event codes that were not reported or information corrected on these forms after your verification;

(2) For each event code provided by the user facility, under § 10416.1(e)(10) or the importer under § 10419.1(e)(10), you must include a statement of whether the type of the event represented by the code is addressed in the device labeling; and

(3) If your report omits any required information, you must explain why this information was not provided and the steps taken to obtain this information.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).