Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3426

2. Registrant Information.

Registrant Reference Number: 120039445

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.

31-MAR-12

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

Unknown

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. 2724-627

Product Name: Zodiac Flea And Tick Powder For Dogs Puppies Cats And Kittens

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1 %
  • PYRETHRINS
    • Guarantee/concentration .1 %

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7. b) Type of formulation.

Dust

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).

Beginning around November 1, 2011, the owner began to apply the product to the cat to treat for fleas, and he applied it every 2 to 3 weeks. The date of the final application is unknown.

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 Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11.0

7. Weight (provide a range if necessary )

2.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 an unknown date, some time after the owner began applying the product to the cat, the owner noticed that the cat was symptomatic. On an unknown date some time after the weight loss began, the owner took the cat to the veterinarian. Around January 31, 2012 the owner observed that the cat died. On March 31, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product has a low concentration of ingredients and that if any signs were seen, they would likely be due to a taste reaction from grooming. The APSS veterinarian also stated that weight loss would not be expected if the product were used per label and that the cat likely died from some other cause. The APSS veterinarian referred the owner to the manufacturer to discuss the situation.

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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

The APSS veterinarian stated that the substance was not considered to be related to the clinical situation. A necropsy was not available because the cat had already been buried.