Mandatory Form Page 2
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1
2Medication and Device
Submission of a report does not constitute
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service • Food and Drug Administration
an admission that medical personnel, user
Experience Report
facility, distributor, manufacturer or product
(continued)
caused or contributed to the event.
Refer to guidelines for specific instructions
Page
____ of ____
FDA Use Only
F. For use by user facility/distributor–devices only
H. Device manufacturers only
1. Check one
2. UF/Dist report number
1. Type of reportable event
2. If follow-up, what type?
user facility
distributor
death
correction
3. User facility or distributor name/address
serious injury
additional information
malfunction (see guidelines)
response to FDA request
other: ________________________
device evaluation
3. Device evaluated by mfr?
4. Device manufacture date
(mo/yr)
not returned to mfr.
yes
evaluation summary attached
4. Contact person
5. Phone Number
5. Labeled for single use?
no (attach page to explain why not)
or provide code:
yes
no
6. Date user facility or distributor
8. Date of this report
7. Type of report
________________________
became aware of event
(mo/day/yr)
initial
(mo/day/yr)
6. Evaluation codes (refer to coding manual)
follow-up # _____
method
9. Approximate
10. Event problem codes (refer to coding manual)
age of device
patient
results
code
device
conclusions
code
11. Report sent to FDA?
12. Location where event occurred
7. If remedial action initiated,
8. Usage of device
yes
hospital
___________________
outpatient
check type
(mo/day/yr)
diagnostic facility
home
no
initial use of device
ambulatory
recall
notification
nursing home
surgical facility
13. Report sent to manufacturer?
reuse
outpatient
repair
inspection
treatment facility
yes
unknown
___________________
other:
replace
(mo/day/yr)
patient monitoring
no
9. If action reported to FDA under
specify
21 USC 360i(f), list correction/removal
relabeling
modification/
14. Manufacturer name/address
reporting number:
adjustment
other:
10.
Additional manufacturer narrative
and/or
11.
Corrected data
G. All manufacturers
1. Contact office – name/address (& mfring site for devices)
2. Phone number
3. Report source
(check all that apply)
foreign
study
literature
consumer
health
4. Date received by manufacturer
professional
5.
(A)
NDA # ___________
(mo/day/yr)
user facility
IND #
___________
company
6. If IND, protocol #
representative
PLA # ___________
distributor
pre-1938
yes
7. Type of report
other:
(check all that apply)
OTC
yes
product
5-day
15-day
8. Adverse event term(s)
10-day
periodic
Initial
follow-up # ____
9. Mfr. report number
The public reporting burden for this collection of information has been estimated to average one-
DHHS Reports Clearance Office
“An agency may not conduct or sponsor,
Please DO NOT RETURN this
hour per response, including the time for reviewing instructions, searching existing data sources,
Paperwork Reduction Project (0910-0291)
and a person is not required to respond to,
form to this address.
gathering and maintaining the data needed, and completing and reviewing the collection of infor-
Hubert H. Humphrey Building, Room 531-H
a collection of information unless it displays
mation. Send comments regarding this burden estimate or any other aspect of this collection of
200 Independence Avenue, S.W.
a currently valid OMB control number.”
information, including suggestions for reducing this burden to:
Washington, D.C. 20201
FDA Form 3500A - back
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