{"data":{"id":"us/21-cfr-803.42","jurisdiction":"us","citation":"21 CFR 803.42","heading":"If I am an importer, what information must I submit in my individual adverse event reports?","body":"You must include the following information in your report, if the information is known or should be known to you, as described in § 803.40. 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) Description of 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 explanation (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 the manufacturer, user facility, 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) Importer information (Form FDA 3500A, Block F). You must submit the following:\n(1) An indication that this is an importer report (by marking the importer box on the form);\n(2) Your importer report 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 report, you must include the report number of your 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 FDA 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 event occurred;\n(13) Whether a 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 D—Importer 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":"d6755bb1b70d74ec8ee0e3443a81e12965e05656ea4f3f2e659467c7229029ad","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-803.40","next":"us/21-cfr-803.50"},"notice":"GroundRules: Original legal text. Not legal advice."}