10419. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS

10419 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS 10419.1 You must include the following information in your report, if the information is known or should be known to you: (a) For patient information, you must submit the following: The patient’s name or other identifier; The patient’s age at the time of event, or date of birth; The patient’s sex; and The patient’s weight; (b) For adverse event or product problem, you must 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) The 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; (6) A description of relevant tests, including dates and laboratory data; and (7) A description of other relevant patient history, including preexisting medical conditions; (c) For device information, you must submit the following: 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); The expiration date; (6) The model, catalog, serial, lot, or other identifying numbers; (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, and 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) The name, address, and telephone number of the reporter who initially provided information to the manufacturer, user facility, 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 importer information, you must submit the following: (1) An indication that this is an importer report (by marking the importer box on the form); (2) Your importer report 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, and year); (7) 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 the device; (11) The event problem codes; (12) Whether a report was sent to the Department and the date it was sent (month, day, and year); (13) The location where event occurred; (14) Whether a report was sent to the manufacturer and the date it was sent (month, day, and 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 § 10419