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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5576

2. Registrant Information.

Registrant Reference Number: 100125179

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

24-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

24-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.       PMRA Submission No.       EPA Registration No. 29909-2-2724

Product Name: Zodiac Fleatrol Flea and Tick Shampoo for Dogs and Cats

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .05 %

7. b) Type of formulation.

Liquid

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 September 24, 2010 the owner bathed the cat with the product.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Retching
  • Respiratory System
    • Symptom - Choking
  • General
    • Symptom - Vocalizing
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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 24, 2010 the cat became symptomatic shortly after the bath. The cat then died a few minutes later. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated this shampoo contains pyrethrins in a low concentration. The APSS veterinarian discussed ruling out hypertrophic cardiomyopathy (HCM) and recommended a necropsy. The APSS veterinarian recommended the owner take the cat's body to the veterinarian, have the veterinarian call for information on the necropsy.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On October 5, 2010 the final necropsy results were received from the U of I. The necropsy results stated the most significant changes are the gross and histologic evidence of cardiomyopathy which most likely resulted in death of this animal, not a toxin from the shampoo.