[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: 21CFR803.32]

[Page 49-50]
 
                        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 C--User Facility Reporting Requirements
 
Sec. 803.32  Individual adverse event report data elements.

    User facility reports shall contain the following information, 
reasonably known to them as described in 803.30(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) Identification of 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 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 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 device was available for evaluation and whether device 
was returned to the manufacturer; 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 telephone 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 initial reporter also sent a copy of the report to FDA, 
if known.
    (e) User facility information (Block F) shall contain the following:
    (1) Whether reporter is a user facility;
    (2) User facility number;
    (3) User facility address;

[[Page 50]]

    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the user facility 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 user facility 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 report was sent to the manufacturer and the date it was 
sent (month, day, year); and
    (14) Manufacturer name and address; if available.