Free 1932 - Federal

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

9a
Form Approved: OMB No. 0910-0284 Expiration Date: January 31, 2010

(Forward to address at left. Attach all correspondence that pertains to this reaction)

Public reporting burden for this collection of information is estimated to average 2 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing 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: Food and Drug Administration An agency may not conduct or sponsor, and a person is not required 7500 Standish Place (HFV-210), Room N403 to respond to, a collection of information unless it displays a currently Rockville, MD 20855 valid OMB control number. 1. REPORT SOURCE AND ADDRESS (Mfr., Distr.)

NOTE: This report is required by law (21 CFR 510.300). Failure to report can result in withdrawal of approval of the application.
2a. DATE REPORT RECEIVED 3a. TYPE OF REPORT
3-day Alert Periodic Report 15-day Alert

b. DATE SENT TO FDA 3b. c. NUMBER OF DAYS BETWEEN 2a AND b: 4. NAME, ADDRESS AND PHONE NO. OF ATTENDING VETERINARIAN (In confidence) Name: Street Address: City: State: ZIP: 5. NAME OR CASE IDENTIFICATION OF OWNER (In confidence)

Initial Report Follow Up Report Of (Give Date)

Phone No. ( __ __ __ ) __ __ __ - __ __ __ __ 6. TRADE NAME AND GENERIC NAME(S) OF ACTIVE INGREDIENT(S) (Include dosage form and strength - Ex., tab, 500 mg.) 7a. NAME OF MANUFACTURER

b. NADA NO. 8. LOT NUMBER(S) 9. DOSAGE ADMINISTERED AND ROUTE (Ex. 250 mg., q 12 h, p.o.) 10. DATE(S) OF ADMINISTRATION

11. ILLNESS/REASON FOR USE OF THIS DRUG

12. DRUG WAS ADMINISTERED BY VETERINARIAN, STAFF OWNER, OTHER

13. NUMBER OF ANIMALS IN THIS INCIDENT a. TREATED WITH DRUG b. REACTED 15. CONCOMITANT MEDICAL PROBLEMS

c. DIED

14. a. SPECIES c. AGE e. SEX FEMALE

REACTING ANIMALS b. BREED d. WEIGHT

MALE

PREGNANT

NEUTERED

16. OVERALL STATE OF HEALTH AT TIME OF REACTION GOOD 18. NAME OF DRUG FAIR POOR CRITICAL

17. DID ANY NEW ILLNESS DEVELOP OR DID INITIAL DIAGNOSIS CHANGE AFTER SUSPECT DRUG STARTED? NO YES (Explain)

CONCOMITANT DRUGS ADMINISTERED ROUTE DOSAGE REGIMEN DATE(S) OF ADMINISTRATION

1. 2. 3. 4. 5. 6. T.
I.L. CR

D PR PO R NC

NAI AI AP AL

FOR FDA USE ONLY COMMENT

CONT
PSC Graphics: (301) 443-1090

FORM FDA 1932 (1/07)

EF

19. DESCRIBE SUSPECTED ADVERSE REACTION: INCLUDE ALL SIGNS, RESULTS OF PERTINENT LAB TESTS, NECROPSY RESULTS, POSSIBLE CONTRIBUTING FACTORS, ETC. ALSO, INCLUDE IN THIS SECTION PRODUCT INEFFECTIVENESS AND PRODUCT DEFECTS SUCH AS CRACKED TABLETS, CLOUDY SOLUTION, ETC.

REACTION DATA

20a. ATTENDING VETERINARIAN'S LEVEL OF SUSPICION THAT DRUG CAUSED REACTION HIGH MEDIUM LOW NO ATTENDING VET.

20b. WAS THERE EXTRA LABEL USE (ELU) INVOLVED?

NO 22. DATE OF ONSET (Mo., day, yr.)

YES (Explain) 23. DURATION OF REACTION (Hrs., days, etc.)

21. LENGTH OF TIME BETWEEN LAST ADMINISTRATION OF SUSPECT DRUG AND ONSET OF REACT

24. WAS THE ADVERSE REACTION TREATED? NO YES (Describe treatment)

25. OUTCOME OF REACTION TO DATE DIED (Give date) REMAINS UNDER TREATMENT ALIVE WITH SEQUELAE RECOVERED UNKNOWN

26. WHEN REACTION APPEARED, TREATMENT WITH SUSPECT DRUG: HAD ALREADY BEEN COMPLETED DISCONTINUED DUE TO THE REACTION DISCONTINUED, REPLACE WITH ANOTHER DRUG DISCONTINUED, REINTRODUCED LATER CONTINUED AT ALTERED DOSE OTHER (Explain) CONTINUED

AND THE REACTION

STOPPED RECURRED OTHER (Explain)

27. HAD ANIMAL(S) BEEN PREVIOUSLY EXPOSED TO THIS DRUG? 28. DID ANIMAL(S) PREVIOUSLY REACT TO THIS DRUG? 29. HAD ANIMAL(S) PREVIOUSLY REACTED TO OTHER DRUGS?

NO NO

YES YES

UNKNOWN UNKNOWN

NO YES UNKNOWN (If yes, give drug(s) and reaction if known)

30. HAS THE ATTENDING VETERINARIAN SEEN SIMILAR REACTIONS TO THIS DRUG IN ANY OTHER ANIMALS? NO YES (Describe treatment)

31. NAME AND TITLE OF INDIVIDUAL RESPONSIBLE FOR ACCURACY OF REPORTED INFORMATION (Type or print)

32. SIGNATURE OF INDIVIDUAL RESPONSIBLE FOR ACCURACY OF REPORTED INFORMATION

FORM FDA 1932 (1/07)