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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6123

2. Registrant Information.

Registrant Reference Number: 10-CA-00044

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.

28-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

17-SEP-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. 22919      PMRA Submission No.       EPA Registration No.

Product Name: Ecto-Soothe Plus Emollient Oatmeal Pesticide Shampoo

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Application occurred on September 16, 2010 at 9:00pm CDT. An unspecified amount of shampoo was applied dermally. the exposure was to treat a condition, and occurred at animal owner home. The use was appropriate. Because the amount was unknown consistent, the patient was considered to be at very low risk of developing clinical signs.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Soft Coated Wheaton Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

12.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Vocalizing

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 September 17, 2010 received report from the NAPCC. On September 16, 2010 at 9:00 pm CDT pet was bathed with unspecified amount of Ecto-Soothe Carbaryl Shampoo used to treat condition. On September 17, 2010, at 3:00 am CDT Owner reported pet vocalizing. Because the time course was poorly consistent, the amount was unknown consistent, and the findings were poorly consistent, this substance was considered to have doubtful likelihood of causing the clinical situation. NAPCC was unable to interact with owner to follow up.


To be determined by Registrant

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

Minor

19. Provide supplemental information here