---
kind: "section"
citation: "21 C.F.R. § 803.42"
title: "21"
number: "803.42"
heading: "If I am an importer, what information must I submit in my individual adverse event reports?"
url: "https://uscodex.org/cfr/21/803.42"
---

# §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](/cfr/21/803.40.md). 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)](#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.**

## Notes

### Amendments

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]

### Authority

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

### Source

Source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.

### Amendments

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]