Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2008-4434

2. Registrant Information.

Registrant Reference Number: 080077100

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.

14-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MINNESOTA

6. Date incident was first observed.

13-JUL-08

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 And Kittens Under 5 Lb

• 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.

.034

Units: oz (fl) / oz (liquide)

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 July 12, 2008, the humane society staff person applied the product to the cat as a preventative measure.

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

Other

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 )

1.5

7. Weight (provide a range if necessary )

9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Chest congestion
  • Specify - lung congestion

• Liver
  • Symptom - Other
  • Specify - liver congestion

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

Sudden death would not be expected from the ingredients in this product. A gross necropsy, performed at the vet clinic, revealed nothing significant. The APSS veterinary recommended tissue samples to be sent for further testing. Samples were not sent.

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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 doubted that this substance was related to causing the clinical situation.