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§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:
(a) Patient information (Form FDA 3500A, Block A). You must submit the following:
(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.
(b) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following:
(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.
(c) Device information (Form FDA 3500A, Block D). You must submit the following:
(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;
(10) 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
(11) Concomitant medical products and therapy dates. (Do not report products that were used to treat the event.)
(d) Initial reporter information (Form FDA 3500A, Block E). You must submit the following:
(1) Name, address, and telephone number of the reporter who initially provided information to you, or to the user facility or importer;
(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.
(e) Reporting information for all manufacturers (Form FDA 3500A, Block G). You must submit the following:
(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.
(f) Device manufacturer information (Form FDA 3500A, Block H). You must submit the following:
(1) Type of reportable event (death, serious injury, malfunction, etc.);
(2) Type of followup report, if applicable (e.g., correction, response to FDA request, etc);
(3) 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;
(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:
(i) 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;
(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
(iii) If your report omits any required information, you must explain why this information was not provided and the steps taken to obtain this information.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]