[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.42]

[Page 51]
 
                        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 D--Importer Reporting Requirements
 
Sec. 803.42  Individual adverse event report data elements.

    Individual medical device importer reports shall contain the 
following information, in so far as the information is known or should 
be known to the importer, as described in Sec. 803.40, 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, that is:
    (i) Death;
    (ii) Life threatening injury or illness;
    (iii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iv) 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 preexisting 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 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) Importer information (Block F) shall contain the following:
    (1) Whether reporter is an importer;
    (2) Importer report number;
    (3) Importer address;
    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the importer became aware of the event (month, day, year);
    (7) Type of report (initial or followup (if followup, include report 
number of initial report));
    (8) Date of the importer report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to FDA 
``Coding Manual For Form 3500A'');
    (11) Whether a report was sent to FDA 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.

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