1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness

Section

1932A
FOLD, SEAL, AND RETURN

DATE REPORTED

VETERINARY ADVERSE DRUG REACTION, LACK OF
EFFECTIVENESS OR PRODUCT DEFECT REPORT

Form Approved: OMB No. 0910-0284
Expiration Date: January 31, 2010

NOTE: This report is authorized by 21 U.S.C 352(a) and (f). While you are not required to report, your cooperation is needed to assure
comprehensive and timely assessment of product labeling.
2. OWNER’S NAME OR CASE ID
(In Confidence)

1. VETERINARIAN’S NAME AND ADDRESS

If you do NOT want
your identity disclosed
to the manufacturer,
place an "X" in this
box.

3. NADA NUMBER (For FDA Use)
TELEPHONE (Include Area Code)

4. SUSPECTED DRUG AND DOSAGE FORM

5. MANUFACTURER’S NAME

6. DIAGNOSIS AND / OR REASON FOR USE OF DRUG

7. ADMINISTERED BY
VETERINARIAN
OWNER

8. DOSAGE ADMINISTERED AND ROUTE (Ex. 250 mg. q 12h, 5 days, orally)

10. SPECIES

11. BREED

9. DATE(S) OF ADMINISTRATION

12. AGE

13. SEX

14. WEIGHT
LBS.

15. CONCURRENT CLINICAL PROBLEMS

16. CONCURRENT DRUGS ADMINISTERED
NONE

NONE

OVERALL STATE OF HEALTH WHEN SUSPECTED DRUG GIVEN:
GOOD

FAIR

POOR

CRITICAL

17. REACTION INFORMATION
a. TIME BETWEEN INITIATION OF THERAPY WITH SUSPECTED DRUG AND ONSET OF REACTION WAS
b. TIME BETWEEN LAST ADMINISTRATION OF SUSPECTED DRUG AND ONSET OF REACTION WAS
c. OUTCOME:

RECOVERED FROM REACTION

d. WAS THE REACTION TREATED?

NO

DIED FROM REACTION

OTHER (Comment Below)

YES (Comment Below)

e. WHEN THE REACTION APPEARED, TREATMENT WITH SUSPECTED DRUG:
HAD ALREADY BEEN COMPLETED
WAS DISCONTINUED DUE TO REACTION

CONTINUED

WAS DISCONTINUED AND REPLACED WITH ANOTHER DRUG
WAS DISCONTINUED AND REINTRODUCED LATER

AND THE
REACTION

STOPPED
RECURRED

WAS CONTINUED AT ALTERED DOSE

OTHER (Comment Below)

OTHER (Comment Below)
f. LEVEL OF SUSPICION THAT DRUG CAUSED THE REACTION:

HIGH

MEDIUM

LOW

18. DESCRIBE THE REACTION, ADD DETAILS ABOUT CASE HISTORY AND OUTCOME (Include numbers if group of animals involved), GIVE COMMENT ON
POSSIBLE CONTRIBUTING FACTORS. DESCRIBE LACK OF EFFECTIVENESS OR PRODUCT DEFECT (Include Expiration Date and Lot No.)

NOTE: Triple fold as marked, seal with tape, no postage required, additional space on back, if needed.

FORM FDA 1932a (3/07)

PSC Graphics (301) 443-1090

EF

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.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, 420A
Rockville, MD 20850
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:
FOLD

NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATES

DEPARTMENT OF
HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville MD 20857
Official Business
Penalty for Private use $300

BUSINESS REPLY MAIL

FIRST CLASS

PERMIT NO. 946

ROCKVILLE MD

POSTAGE WILL BE PAID BY FOOD AND DRUG ADMINISTRATION

Department of Health and Human Services
Food and Drug Administration
CVM-HFV-210 (0910-0012)
7500 Standish Place
Rockville, MD 20855

FOLD

THANK YOU FOR SHARING YOUR CONCERN ABOUT ANIMAL DRUG EFFECTS
18. (Continued)

FOR FDA USE ONLY
1.

D

NAI

2.

PR

AI

3.

PO

AP

R

AL

4.
5.

NC

6.
T.

I.L.

CR

CONT

Confidentiality: The owner’s identity is
held in strict confidence by FDA and
protected to the fullest extent of the law.
The reporter’s identity, including the
identity of self-reporter, may be shared
with the manufacturer unless requested
otherwise. However, FDA will not disclose
the reporter’s identity in response to a
request from the public, pursuant to the
Freedom of Information Act.

COMMENT

WHEN MAILING FOLD THIS SECTION INSIDE