Section 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;(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;(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:(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;(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;(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(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