{"data":{"id":"us/21-cfr-803.52","jurisdiction":"us","citation":"21 CFR 803.52","heading":"If I am a manufacturer, what information must I submit in my individual adverse event reports?","body":"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:\n(a) Patient information (Form FDA 3500A, Block A). You must submit the following:\n(1) Patient name or other identifier;\n(2) Patient age at the time of event, or date of birth;\n(3) Patient gender; and\n(4) Patient weight.\n(b) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following:\n(1) Identification of adverse event or product problem;\n(2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is:\n(i) A life-threatening injury or illness;\n(ii) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or\n(iii) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function;\n(3) Date of event;\n(4) Date of this report;\n(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;\n(6) Description of relevant tests, including dates and laboratory data; and\n(7) Other relevant patient history including preexisting medical conditions.\n(c) Device information (Form FDA 3500A, Block D). You must submit the following:\n(1) Brand name;\n(2) Product Code, if known, and Common Device Name;\n(3) Manufacturer name, city, and state;\n(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;\n(5) Operator of the device (health professional, lay user/patient, other);\n(6) Date of device implantation (month, day, year), if applicable;\n(7) Date of device explantation (month, day, year), if applicable;\n(8) Whether the device is a single-use device that was reprocessed and reused on a patient (Yes, No)?\n(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;\n(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\n(11) Concomitant medical products and therapy dates. (Do not report products that were used to treat the event.)\n(d) Initial reporter information (Form FDA 3500A, Block E). You must submit the following:\n(1) Name, address, and telephone number of the reporter who initially provided information to you, or to the user facility or importer;\n(2) Whether the initial reporter is a health professional;\n(3) Occupation; and\n(4) Whether the initial reporter also sent a copy of the report to us, if known.\n(e) Reporting information for all manufacturers (Form FDA 3500A, Block G). You must submit the following:\n(1) Your reporting office's contact name and address and device manufacturing site;\n(2) Your contact person's telephone number;\n(3) Your report sources;\n(4) Date received by you (month, day, year);\n(5) PMA/510k Number and whether or not the product is a combination product;\n(6) Type of report being submitted (e.g., 5-day, initial, followup); and\n(7) Your report number.\n(f) Device manufacturer information (Form FDA 3500A, Block H). You must submit the following:\n(1) Type of reportable event (death, serious injury, malfunction, etc.);\n(2) Type of followup report, if applicable (e.g., correction, response to FDA request, etc);\n(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;\n(4) Device manufacture date (month, day, year);\n(5) Whether the device was labeled for single use;\n(6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) (refer to FDA MedWatch Medical Device Reporting Code Instructions);\n(7) Whether remedial action was taken and the type of action;\n(8) Whether the use of the device was initial, reuse, or unknown;\n(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\n(10) Your additional narrative; and/or\n(11) Corrected data, including:\n(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;\n(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\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 803—MEDICAL DEVICE REPORTING","Subpart E—Manufacturer Reporting Requirements"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"8ac54453baf30d05a2c0cb510628b1b48d2fefad4bcf1ac267297da9c68c7b75","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-803.50","next":"us/21-cfr-803.53"},"notice":"GroundRules: Original legal text. Not legal advice."}