Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3455

2. Registrant Information.

Registrant Reference Number: 2013-US-03429

Registrant Name (Full Legal Name no abbreviations): Virbac Animal Health

Address: 3200 Meacham Blvd.

City: Fort Worth

Prov / State: TX

Country: United States

Postal Code: 76137

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

26-MAR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

23-MAR-13

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2382-104

Product Name: Preventic Collar for Dogs 25"

• Active Ingredient(s)
  • AMITRAZ
    • Guarantee/concentration 9 %

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7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On 03/26/2013, sponsor was contacted to report an apparent adverse reaction to the PREVENTIC (25/9% Amitraz) Tick Collar for Dogs. According to the veterinarian the animal owner had applied the collar to the dog on 02/11/2013 for tick prevention.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 03/26/2013, sponsor was contacted to report an apparent adverse reaction to the PREVENTIC (25/9% Amitraz) Tick Collar for Dogs. According to the veterinarian the animal owner had applied the collar to the dog on 02/11/2013 for tick prevention. The animal owner contacted the clinic on 03/23/2013 to report the dog was found dead in the back yard that day. The animal owner reported that another dog had been wearing the same collar in 01/2013 and was found dead in her run on 02/10/2013. The collar was then applied to this dog on 02/11/2013. The veterinarian reported that the animal owner contacted the clinic because the PREVENTIC Collar was the only thing the two dogs shared. The veterinarian also reported she had never seen or examined this dog before. Sponsor discussed with the veterinarian the mode of action of the collar and confirmed that the collar had not been chewed on. The veterinarian reported she did not think the deaths were related to the PREVENTIC collar and stated that the dogs live out in the country and it could have been anything that caused the events. This dog lived outside, was not fenced in, and had free run, per the veterinarian. Neither dog had a necropsy performed, per the veterinarian. No further information is expected. See case 2013-US-03410 for the first dog.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Sponsor veterinarian noted the adverse event was not likely attributable to the product. The event occurred almost six weeks after the collar had been placed on the dog. There was no indication of ingestion of the product and the attending veterinarian reported the dog lived in a rural area and may have been exposed to something else.