[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

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  If I am a user facility, what information must I submit in 

my individual adverse event reports?



    You must include the following information in your report, if 

reasonably known to you, as described in Sec.  803.30(b). These types of 

information correspond generally to the elements 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 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 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 explantation (month, day, year);

    (9) Whether the device was available for evaluation and whether the 

device was returned to the manufacturer; if



[[Page 50]]



so, the date it was returned to the manufacturer; and

    (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 you, or to the 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 

us, if known.

    (e) User facility information (Form 3500A, Block F). You must submit 

the following:

    (1) An indication that this is a user facility report (by marking 

the user facility box on the form);

    (2) Your user facility 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, you 

must include the report number of the 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 the 

``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 the event occurred;

    (13) Whether the report was sent to the manufacturer and the date it 

was sent (month, day, year); and

    (14) Manufacturer name and address, if available.