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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5707

2. Registrant Information.

Registrant Reference Number: 2011-US-07428

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

Address: 3200 Meacham Blvd.

City: Fort 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.

09-AUG-11

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

08-AUG-11

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

Product Name: Preventic Amitraz Tick Collar for Dogs 18"

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

7. b) Type of formulation.

Other (specify)

Collar

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 08/09/2011, NAPCC was contacted to report an apparent adverse reaction to the PREVENTIC 18" (9% Amitraz) Tick Collar for Dogs. According to the report, the animal owner had five stray kittens that were exposed to the Preventic collar that was on their dog on approximately 08/08/2011. Note from attending veterinarian, (name): The kittens were found. One has always had neurologic signs. Yesterday morning two kittens began seizing and died within a few hours. Three kittens were brought into the clinic this morning. One was not walking, had a head tilt, bradycardic, dehydrated, and had a temperature of 94. That kitten was euthanized. The other two kittens are acting fine. The owner had used the floor cleaner in the kitchen two days ago. The kittens were never in the kitchen. The caller also used a Preventic collar on one of her other pets. According to the report, the kitten that was euthanized on 08/09/2011, also had a necropsy performed. No necropsy results were provided in the report. The report listed the potential causes as: Preventic Collar, Feline Leukemia Virus, and Toxoplasmosis. No further information is available at this time. On 08/17/2011, NAPCC attempted to contact the animal owner to update the case. NAPCC left a voice message for a return call, and the animal owners have not returned the call. No necropsy results were provided in the final report. Case has been closed. No further information is expected.

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

Cat / Chat

3. Breed

Unknown Domestic Feline

4. Number of animals affected

3

5. Sex

Unknown

6. Age (provide a range if necessary )

0.077

7. Weight (provide a range if necessary )

1

lbs

8. Route(s) of exposure

Skin

Oral

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Head tilt
    • Symptom - Seizure
  • Cardiovascular System
    • Symptom - Bradycardia
  • General
    • Symptom - Hypothermia
    • Symptom - Dehydration

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.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

16. How was the animal exposed?

Other / Autre

specify The kittens have been playing with two dogs who each have a Preventic collar on.

17. Provide any additional details about the incident

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

Three kittens were treated with unspecified subcutaneous fluids. Kitten that was euthanized had a complete blood count performed and was normal.


To be determined by Registrant

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

Death

19. Provide supplemental information here

None reported.