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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6062

2. Registrant Information.

Registrant Reference Number: 2010-CA-00014

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

Address: 3200 Meacham Blvd.

City: Ft. Worth

Prov / State: Texas

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.

30-APR-10

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

30-APR-10

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)

PMRA Registration No. 24496      PMRA Submission No.       EPA Registration No. 2382-104

Product Name: Preventic Amitraz Tick Collar for Dogs 25"

  • Active Ingredient(s)
    • AMITRAZ

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

9

Units: %

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 April 30 Virbac received report from NAPCC of adverse reaction from Preventic Amitraz Tick Collar for Dogs 25" . Owner saw the dog chewing on the collar this at 10 am CDT. No parts of the collar were ingested. Just recently (approximately 3:34pm), the dog has become lethargic, not herself. Dog is eating and drinking, no vomiting. Owner reports she was able to stand and walk with no problems. Owner removed the collar and gave 1/2 cup milk. Pet made full recovery with home treatment as reported April 30, 2010.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

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

Lethargic approximately 7hrs. Owner gave 1/2 cup of milk at 2:15 PM. Owner removed collar at 2:40 PM.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

none reported.