10416. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES

10416 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES 10416.1 A user facility shall include the following information in its report, if reasonably known: (a) For patient information, the user facility shall submit the following: (1) The patient’s name or other identifier; (2) The patient’s age at the time of event, or date of birth; (3) The patient’s sex; and (4) The patient’s weight; (b) For an adverse event or product problem, the user facility shall submit the following: (1) Identification of the adverse event or product problem; (2) Outcomes attributed to the adverse event (for example, death or serious injury). An outcome is considered a serious injury if it is: (A) A life-threatening injury or illness; (B) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (C) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function; (3) The date of the event; (4) The date of report by the initial reporter; (5) A description of 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; (6) A description of relevant tests, including dates and laboratory data; and (7) A description of other relevant history, including preexisting medical conditions; (c) For device information, you must submit the following: (1) The brand name; (2) The type of device; (3) The manufacturer’s name and address; (4) The operator of the device (health professional, patient, lay user, other); (5) The expiration date; (6) The model, catalog, serial, lot, or other identifying number; (7) The date of device implantation (month, day, and year); (8) The date of device expiration (month, day, and year); (9) Whether the device was available for evaluation and whether the device was returned to the manufacturer; if so, the date it was returned to the manufacturer; and (10) Concomitant medical products and therapy dates; (d) For initial reporter information, you must submit the following: (1) Name, address, and telephone number of the reporter who initially provided information to you, or to the manufacturer or distributor; (2) Whether the initial reporter is a health professional; (3) Occupation; and (4) Whether the initial reporter also sent a copy of the report to the Department, if known; and (e) For user facility information, you must submit the following: (1) An indication that this is a user facility report (by marking the user facility box on the form); (2) Your user facility number; (3) Your address; (4) Your contact person; (5) Your contact person's telephone number; (6) The date that you became aware of the event (month, day, year); (7) The type of report (initial or follow-up); (8) The report number of the initial report, if a follow-up report; (9) The date of the report (month, day, and year); (10) The approximate age of device; (11) The event problem codes--patient code and device code (refer to the "MEDWATCH Medical Device Reporting Code Instructions"); (12) Whether a report was sent to the Department and the date it was sent (month, day, and year); (13) The location where the event occurred; (14) Whether the report was sent to the manufacturer and the date it was sent (month, day, year); and (15) The manufacturer’s name and address, if available. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10416