[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.42]

[Page 56-57]
 
                        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  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 Sec.  
803.40. These types of information correspond generally to the format of 
FDA Form 3500A:
    (a) Patient information (Form 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 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) 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, 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 3500A, Block D). You must submit 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 explanation (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

[[Page 57]]

    (10) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form 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 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.