Free 1932a - Federal

Section
FOLD, SEAL, AND RETURN

1932A
DATE REPORTED Form Approved: OMB No. 0910-0284 Expiration Date: January 31, 2010

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

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.
1. VETERINARIAN'S NAME AND ADDRESS

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

2. OWNER'S NAME OR CASE ID (In Confidence)

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)

9. DATE(S) OF ADMINISTRATION

10. SPECIES

11. BREED

12. AGE

13. SEX

14. WEIGHT
LBS.

15. CONCURRENT CLINICAL PROBLEMS
NONE

16. CONCURRENT DRUGS ADMINISTERED
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 NO DIED FROM REACTION YES (Comment Below) OTHER (Comment Below)

d. WAS THE REACTION TREATED?

e. WHEN THE REACTION APPEARED, TREATMENT WITH SUSPECTED DRUG: HAD ALREADY BEEN COMPLETED WAS DISCONTINUED DUE TO REACTION WAS DISCONTINUED AND REPLACED WITH ANOTHER DRUG WAS DISCONTINUED AND REINTRODUCED LATER WAS CONTINUED AT ALTERED DOSE OTHER (Comment Below) f. LEVEL OF SUSPICION THAT DRUG CAUSED THE REACTION: HIGH MEDIUM

AND THE REACTION

*
LOW

CONTINUED STOPPED RECURRED OTHER (Comment Below)

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)

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

18. (Continued)

1. 2. 3. 4. 5. 6. T.

I.L.

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.

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

THANK YOU FOR SHARING YOUR CONCERN ABOUT ANIMAL DRUG EFFECTS

D PR PO R NC

NAI AI AP AL

CR

CONT

Department of Health and Human Services Food and Drug Administration CVM, HFV-210 (0910-0012) 7500 Standish Place Rockville, MD 20855
NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES

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

FOR FDA USE ONLY
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