Form 3419 User Facility Annual Report Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

MEDICAL DEVICE REPORTING
ANNUAL USER FACILITY REPORT

CDRH Medical Device Reporting
P.O. Box 3002
Rockville, MD 20847-3002

OMB: 0910-0437
Exp. Date: 07/31/2012

PART 1 - COVER SHEET

If MDR reports were not submitted to either the FDA or a device manufacturer during this reporting period, DO NOT submit an
annual report.

PART 1 INSTRUCTIONS
Complete one copy of the following information as a cover page for the annual report and return to the address listed
above. This report should NOT include reports that are not required but have been submitted voluntarily.
2. USER FACILITY ID (HCFA OR FDA PROVIDED NUMBER)

1. REPORT PERIOD
JAN - DEC

Y

Y

Y

Y

3. USER FACILITY INFORMATION
a. Name

4. USER FACILITY CONTACT INFORMATION
a. Name

b. Street Address

b. Street Address

c. City

d. State

e. ZIP Code

c. City

f. Country/Postal Code (if not U.S.)

d. State

e. ZIP Code

f. Country/Postal Code (if not U.S.)

g. Telephone Number (Include area code and extension)

(

)

5. TOTAL NUMBER OF REPORTS ATTACHED OR SUMMARIZED
a. Lowest Report Number

b. Highest Report Number

(HCFA or FDA Provided No.)

(HCFA or FDA Provided No.)

-

(Year)

(Year)

-

(Sequence No.)

(Sequence No.)

For each report in the range of report numbers listed above, attach a completed copy of Part 2 of this form, or a photocopy of the completed
MedWatch FDA Form 3500A for the event that was sent to FDA and/or the manufacturer. In addition, attach a sheet listing report numbers in the
above range that are not included in this report and explain why.
6. SIGNATURE OF CONTACT

7. DATE OF REPORT
M M

/

D D

/

Y

Y

Y

Y

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, Room 400
Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number.

FORM FDA 3419 (9/10)

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PSC Graphics (301) 443-1090

EF

MEDICAL DEVICE REPORTING
ANNUAL USER FACILITY REPORT
PART 2 - SUMMARY OF EVENT
PART 2 INSTRUCTIONS
If photocopies of previously submitted FDA Form 3500A (MedWatch) are not provided for each MDR reportable
event, complete one copy of the following for each MDR report submitted to FDA and/or the manufacturer during the
calendar year covered by this Annual Report.
1. USER FACILITY EVENT REPORT NUMBER

(HCFA or FDA Provided No.)

-

(Year)

-

(Sequence No.)

2. WHERE WAS REPORT SUBMITTED? (Check all that apply)
FDA

Manufacturer

Distributor

Other

3. MANUFACTURER INFORMATION
a. Name

4. DEVICE INFORMATION
a. Brand Name

b. Common Name
b. Street Address
c. Model Number
c. City

d. State

e. ZIP Code

d. Serial Number
e. Lot Number

f. Country/Postal Code (if not U.S.)
f. Catalog Number
5. BRIEF DESCRIPTION OF EVENT

FORM FDA 3419 (9/10)

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