Section 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?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:
(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) Description of 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 explanation (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 the manufacturer, user facility, or distributor;(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) Importer information (Form FDA 3500A, Block F). You must submit the following:(1) An indication that this is an importer report (by marking the importer box on the form);(2) Your importer report number;(5) Your contact person's telephone number;(6) Date that you became aware of the event (month, day, year);(7) Type of report (initial or followup). If it is a followup report, you must include the report number of your initial report;(8) Date of your report (month, day, year);(9) Approximate age of device;(10) Event problem codes-patient code and device code (refer to FDA MedWatch Medical Device Reporting Code Instructions);(11) Whether a report was sent to us and the date it was sent (month, day, year);(12) Location where event occurred;(13) Whether a report was sent to the manufacturer and the date it was sent (month, day, year); and(14) Manufacturer name and address, if available.79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015