{"data":{"id":"us/21-cfr-803.32","jurisdiction":"us","citation":"21 CFR 803.32","heading":"If I am a user facility, what information must I submit in my individual adverse event reports?","body":"You must include the following information in your report, if reasonably known to you, as described in § 803.30(b). These types of information correspond generally to the elements 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 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) Description of other relevant 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; 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 manufacturer or distributor;\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) User facility information (Form FDA 3500A, Block F). You must submit the following:\n(1) An indication that this is a user facility report (by marking the user facility box on the form);\n(2) Your user facility number;\n(3) Your address;\n(4) Your contact person;\n(5) Your contact person's telephone number;\n(6) Date that you became aware of the event (month, day, year);\n(7) Type of report (initial or followup); if it is a followup, you must include the report number of the initial report;\n(8) Date of your report (month, day, year);\n(9) Approximate age of device;\n(10) Event problem codes—patient code and device code (refer to the “MedWatch Medical Device Reporting Code Instructions”);\n(11) Whether a report was sent to us and the date it was sent (month, day, year);\n(12) Location where the event occurred;\n(13) Whether the report was sent to the manufacturer and the date it was sent (month, day, year); and\n(14) Manufacturer name and address, if available.","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 C—User Facility 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":"1e749bf3c8fef6809a33ee95d8d1a29cf9dbb3c9ca875fc40be7d7fedf5bab87","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-803.30","next":"us/21-cfr-803.33"},"notice":"GroundRules: Original legal text. Not legal advice."}