21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?
You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b). These types of information correspond generally to the format of Form FDA 3500A:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(1) Identification of adverse event or product problem;
(2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is:
(i) A life-threatening injury or illness;
(ii) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or
(iii) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of this report;
(5) Description of the 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;
(6) Description of relevant tests, including dates and laboratory data; and
(7) Other relevant patient history including preexisting medical conditions.
(1) Brand name;
(2) Product Code, if known, and Common Device Name;
(3) Manufacturer name, city, and state;
(4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package;
(5) Operator of the device (health professional, lay user/patient, other);
(6) Date of device implantation (month, day, year), if applicable;
(7) Date of device explantation (month, day, year), if applicable;
(8) Whether the device is a single-use device that was reprocessed and reused on a patient (Yes, No)?
(9) If the device is a single-use device that was reprocessed and reused on a patient (yes to paragraph (c)(8) of this section), the name and address of the reprocessor;
(11) Concomitant medical products and therapy dates. (Do not report products that were used to treat the event.)
(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 us, if known.
(1) Your reporting office's contact name and address and device manufacturing site;
(2) Your contact person's telephone number;
(3) Your report sources;
(4) Date received by you (month, day, year);
(5) PMA/510k Number and whether or not the product is a combination product;
(6) Type of report being submitted (e.g., 5-day, initial, followup); and
(7) Your report number.
(2) Type of followup report, if applicable (e.g., correction, response to FDA request, etc);
(4) Device manufacture date (month, day, year);
(5) Whether the device was labeled for single use;
(6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) (refer to FDA MedWatch Medical Device Reporting Code Instructions);
(7) Whether remedial action was taken and the type of action;
(8) Whether the use of the device was initial, reuse, or unknown;
(9) Whether remedial action was reported as a removal or correction under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and if it was, provide the correction/removal report number; and
(10) Your additional narrative; and/or
(11) Corrected data, including:
(ii) For each event code provided by the user facility under § 803.32(e)(10) or the importer under § 803.42(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
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 803.