§ 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]