---
kind: "section"
citation: "21 C.F.R. § 803.52"
title: "21"
number: "803.52"
heading: "If I am a manufacturer, what information must I submit in my individual adverse event reports?"
url: "https://uscodex.org/cfr/21/803.52"
---

# §803.52. If I am a manufacturer, what information must I submit in my individual adverse event reports?


You must include the following information in your reports, if known or reasonably known to you, as described in [§ 803.50(b)](/cfr/21/803.50.md?p=b). 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) **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 explantation (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 you, or to the user facility or importer;
  - (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) **Reporting information for all manufacturers (Form FDA 3500A, Block G).** You must submit the following:
  - (1) Your reporting office's contact name and address and device manufacturing site;
  - (2) Your contact person's telephone number;
  - (3) Your report sources;
  - (4) Date received by you (month, day, year);
  - (5) PMA/510k Number and whether or not the product is a combination product;
  - (6) Type of report being submitted (e.g., 5-day, initial, followup); and
  - (7) **Your report number.**
- (f) **Device manufacturer information (Form FDA 3500A, Block H).** You must submit the following:
  - (1) Type of reportable event (death, serious injury, malfunction, etc.);
  - (2) Type of followup report, if applicable (e.g., correction, response to FDA request, etc);
  - (3) If the device was returned to you and evaluated by you, you must include a summary of the evaluation. If you did not perform an evaluation, you must explain why you did not perform an evaluation;
  - (4) Device manufacture date (month, day, year);
  - (5) Whether the device was labeled for single use;
  - (6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) (refer to FDA MedWatch Medical Device Reporting Code Instructions);
  - (7) Whether remedial action was taken and the type of action;
  - (8) Whether the use of the device was initial, reuse, or unknown;
  - (9) Whether remedial action was reported as a removal or correction under [section 519(f)](/cfr/21/519.md?p=f) of the Federal Food, Drug, and Cosmetic Act, and if it was, provide the correction/removal report number; and
  - (10) Your additional narrative; and/or
  - (11) **Corrected data, including—**
    - (i) Any information missing on the user facility report or importer report, including any event codes that were not reported, or information corrected on these forms after your verification;
    - (ii) For each event code provided by the user facility under [§ 803.32(e)(10)](/cfr/21/803.32.md?p=e-10) or the importer under [§ 803.42(e)(10)](/cfr/21/803.42.md?p=e-10), you must include a statement of whether the type of the event represented by the code is addressed in the device labeling; and
    - (iii) If your report omits any required information, you must explain why this information was not provided and the steps taken to obtain this information.

## 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]