Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2861

2. Registrant Information.

Registrant Reference Number: 130028955

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.

07-MAR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

07-MAR-13

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. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control For Cats 5 lbs and Over

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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).

On March 6, 2013 the owner applied the product to the cat.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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 )

0.58

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• 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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On the morning of March 7, 2013 the owner discovered the cat had died. A short time later, the owner took the cat's body to her regular veterinarian. Later that morning, the owner's regular veterinary staff contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated death would not be expected from the use of the product. The APSS veterinarian recommended that the owner have a necropsy for the cat.

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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

Later on the morning of March 7, 2013 the owner's regular veterinary staff called the APSS to discuss the necropsy. On March 22, 2013 final necropsy results were received. COMMENTS: The gross and histological findings are consistent with hypertrophic cardiomyopathy, which possibly played an integral role in the demise of this animal. The APSS veterinarian stated that the substance was not considered to be related to the clinical situation.