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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-8105

2. Registrant Information.

Registrant Reference Number: 2016-CA-00218

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.

20-AUG-16

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

19-AUG-16

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. 24459      PMRA Submission No.       EPA Registration No.

Product Name: PREVENTIC L.A. Residual Flea and Tick Spray For Dogs

  • Active Ingredient(s)
    • PERMETHRIN

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).

On 20 Aug 2016, the NAPCC was contacted by an animal owner to report an apparent adverse reaction to PREVENTIC L.A. (2.0% Permethrin) Residual Flea and Tick Spray For Dogs. According to the NAPCC report, on 18 Aug 2016 the animal owner's children saturated their cat with the PREVENTIC L.A. spray and lathered it up as though they were bathing the cat.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

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 )

5.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Skin
    • Symptom - Other
    • Specify - Skin warm to the touch
  • Nervous and Muscular Systems
    • Symptom - Shaking

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Other / Autre

specify Accidental exposure

17. Provide any additional details about the incident

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

On 20 Aug 2016, the NAPCC was contacted by an animal owner to report an apparent adverse reaction to PREVENTIC L.A. (2.0% Permethrin) Residual Flea and Tick Spray For Dogs. According to the NAPCC report, on 18 Aug 2016 the animal owner's children saturated their cat with the PREVENTIC L.A. spray and lathered it up as though they were bathing the cat. The animal owner discovered the cat and bathed it within twenty minutes of exposure, then repeated bathing two to three times with Pantene Pro-V shampoo. The animal owner suspected that the cat may have licked some of the product. In the morning of 19 Aug 2016, the cat was observed to be ataxic, especially when it jumped off the bed and lost its balance. Prior to contacting the NAPCC on 20 Aug 2016, the animal owner bathed the cat again and noted that the cat felt warm to the touch, so used cool water while bathing. Afterward, the cat developed shaking like it was cold. The animal owner indicated that the cat had earmites so would shake its head intermittently. A veterinarian with the NAPCC discussed that it was unknown if the reported signs were attributed to the product exposure due to the duration since exposure and the possibility of other medical conditions contributing to the clinical signs, such as ear mites or inner ear issues. The veterinarian recommended to discontinue bathing the cat and take it to a veterinarian for evaluation.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

According to the NAPCC report, because the time course was poorly consistent, the amount was somewhat consistent, and the findings were poorly consistent, this substance was considered to have low likelihood of causing the clinical situation.