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§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;
(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) Description of 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 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;
(3) Occupation; and
(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;
(3) Your address;
(4) Your contact person;
(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]