[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.52]

[Page 52-53]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 803--MEDICAL DEVICE REPORTING--Table of Contents
 
             Subpart E--Manufacturer Reporting Requirements
 
Sec. 803.52  Individual adverse event report data elements.

    Individual medical device manufacturer reports shall contain the 
following information, known or reasonably known to them as described in 
Sec. 803.50(b), which corresponds to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain 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 (Block B) shall contain the 
following:
    (1) Adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body function 
or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem to include 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 pre-existing medical 
conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number or other 
identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation, and whether the 
device was returned to the manufacturer, and

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if so, the date it was returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, manufacturer, 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 
FDA, if known.
    (e) All manufacturers (Block G) shall contain the following:
    (1) Contact office name and address and device manufacturing site;
    (2) Telephone number;
    (3) Report sources;
    (4) Date received by manufacturer (month, day, year);
    (5) Type of report being submitted (e.g., 5-day, initial, 
supplemental); and
    (6) Manufacturer report number.
    (f) Device manufacturers (Block H) shall contain 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 the manufacturer and evaluated by 
the manufacturer, a summary of the evaluation. If no evaluation was 
performed, provide an explanation why no evaluation was performed;
    (4) Device manufacture date (month, day, year);
    (5) Was device labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA ``Coding Manual for Form 
3500A'');
    (7) Whether remedial action was taken and type;
    (8) Whether use of device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the act (list the correction/removal report 
number); and
    (10) Additional manufacturer narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or 
distributor report, including missing event codes, or information 
corrected on such forms after manufacturer verification;
    (ii) For each event code provided by the user facility under 
Sec. 803.32(d)(10) or a distributor, a statement of whether the type of 
the event represented by the code is addressed in the device labeling; 
and
    (iii) If any required information was not provided, an explanation 
of why such information was not provided and the steps taken to obtain 
such information.