21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?
You must include the following information in your report, if reasonably known to you, as described in § 803.30(b). These types of information correspond generally to the elements of FDA Form 3500A:
(2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is:
(ii) Disability resulting in permanent impairment of a body function or permanent damage to a body structure; or
(iii) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function;
(5) Description of event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event;
(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. (Do not report products that were used to treat the event.)
(1) Name, address, and telephone number of the reporter who initially provided information to you, or to the manufacturer or distributor;
(1) An indication that this is a user facility report (by marking the user facility box on the form);
(7) Type of report (initial or followup); if it is a followup, you must include the report number of the initial report;
(10) Event problem codes—patient code and device code (refer to the “MEDWATCH Medical Device Reporting Code Instructions”);
(13) Whether the report was sent to the manufacturer and the date it was sent (month, day, year); and
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.