Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1791

2. Registrant Information.

Registrant Reference Number: 120149183

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.

25-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: MINNESOTA

6. Date incident was first observed.

09-OCT-12

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. 13799-20

Product Name: Four Paws Ear Mite Remedy For Cats

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1.05 %
  • PYRETHRINS
    • Guarantee/concentration .1 %

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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 an unknown date, the owner suspects that her ex poisoned the dog by giving an unknown amount of the product orally.

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

Dog / Chien

3. Breed

Schipperke

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Oral

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 - Disorientation

• Gastrointestinal System
  • Symptom - Vomiting

• 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?

Intentional poison./Empois. intentionnel

17. Provide any additional details about the incident

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

On October 9, 2012 the owner's son noticed that the dog was disoriented. On October 11, 2012 the owner noticed that the dog had an isolated episode of vomiting; the vomit consisted of orange bile. Later that morning, the owner observed that the dog died. On October 25, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that a topical reaction could be seen in a sensitive individual but that the signs the dog exhibited would not be expected to occur. A necropsy was not available.

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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 causing the clinical situation. A follow up was not performed, because additional information was not expected and signs were not believed to be related to product use. Suspected exposure to oral poison by ex husband.