Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8869

2. Registrant Information.

Registrant Reference Number: 070073875

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.

16-JUL-07

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

16-JUL-07

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. 2724488

Product Name: Zodiac Fleatrol Spot On Special Formula For Cats and Kittens - All Yel

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 July 15, 2007 at 9:00 pm CDT, the owner appropriately applied the said product to the animal to treat for fleas. On July 14, 2007 at 10:00 am CDT, the owner had bathed the animal with a flea and tick shampoo.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Siamese Cat

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

.22

7. Weight (provide a range if necessary )

2.5

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?

Unknown / Inconnu

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 July 16, 2007 at 11:00 am, CDT, 14 hours after the owner applied the said product, the owner noted that the animal had died. The APSS staff member stated that she would not expect serious problems from this exposure and also noted that the animals death was not likely correlated with the exposure. The APSS staff member stated that the death was more likely caused by a trauma and recommended that a necropsy be performed to determine the exact cause of death. Necropsy Results: A 6 X 0.75 cm piece of blue ribbon was found in the stomach. Ectoparasitism was diagnosed upon morphologic diagnosis. Microscopic diagnosis revealed moderate to severe liver damage. The findings suggest that the animal was anemic and hypoxic. Pathologist stated " Liver changes are most consistent with steroid hepatopathy most likely due to stress. An already anemic and hypoxic animal further stressed by application of a flea product may develop a peracute cardiac arrhythmia which often results in no significant histologic changes."

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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

APSS stated this substance was considered not to be the cause of the clinical situation.