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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6063

2. Registrant Information.

Registrant Reference Number: 10-CA-00017

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.

07-MAY-10

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

23-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 Collar (9%/Amitraz)

  • 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 May 7, 2010 Virbac was contacted by hospital to report an apparent adverse reaction with the Preventic Amitraz 25"Tick Collar for dogs. At an unspecified time on April 22, 2010 the collar (25") was attached around the dogs neck by the owner and within 10 hours at unspecified time on April 23, 2010 the dog became lethargic, not eating, and not drinking. Owner removed the collar at unspecified time on April 23, 2010 and within 24 hours and unspecified time the dog recovered. Hospital reported that the pet has used the collars in the past with no issues. Pet was on unspecified dose of PROIN for urinary incontinence.

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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

19

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Adipsia
    • Specify - not drinking.

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 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?

Treatment / Traitement

17. Provide any additional details about the incident

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


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Reported by the Hospital, pet is on the medication Proin for urinary incontinence. Collar was pulled for investigation. First investigation showed that there were no anomaly during manufacturing and control processes. Batch has been released within the specs. same bulk has been used for Preventic 25 inch lot 2MCZ. no other batch or country are concerned.