Form Fda 3419 (3/16) - Medical Device Reporting Annual User Facility Report Form Page 2
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2MEDICAL 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
4. DEVICE INFORMATION
a. Name
a. Brand Name
b. Common Name
b. Street Address
c. Model Number
c. City
d. Serial Number
d. State
e. ZIP Code
e. Lot Number
f. Country/Postal Code (if not U.S.)
f. Catalog Number
5. BRIEF DESCRIPTION OF EVENT
FORM FDA 3419 (3/16)
PAGE 2
(Continue on a separate sheet, if necessary)
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