Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3866

2. Registrant Information.

Registrant Reference Number: 110080390

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.

26-JUN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

26-JUN-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-792

Product Name: Zodiac Flea And Tick Shampoo For Dogs And Cats

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

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-401

Product Name: Zodiac Fleatrol Carpet And Upholstery Pump Spray

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .01 %
  • PERMETHRIN
    • Guarantee/concentration .28 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

Units: mL

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).

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

Maine Coon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

13.0

lbs

8. Route(s) of exposure

Skin

Unknown

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Retching

• General
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Heavy breathing

• Gastrointestinal System
  • Symptom - Drooling

• General
  • 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?

Other / Autre

specify The cat was exposed to the spray product by an unknown route after the owner sprayed the carpet, and the shampoo was applied to the cat later that evening.

17. Provide any additional details about the incident

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

On June 18, 2011, the owner applied a flea and tick spot on to the cat. On June 26, 2011, the owner sprayed the carpet with the Zodiac Fleatrol Spray to treat for fleas, and the cat was likely exposed. Later that evening, the owner bathed the cat with the Zodiac Flea and Tick shampoo, and shortly after the cat became symptomatic. About an hour later, the cat began vomiting. The cat vocalized later that evening, and the owner found the cat had died half an hour later. Shortly after the cat died, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the concentration of ingredients in the shampoo product were very low and severe signs would not be expected from its use. The APSS veterinarian stated that at most, a dermal reaction could be seen from the use of the product.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

An APSS technician recommended a necropsy, and the owner took the cat to a local veterinarian to have the body prepared and sent for a necropsy. The veterinary staff at the clinic contacted the APSS to discuss necropsy details. The necropsy results determined the cat died from heart disease.