Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6013

2. Registrant Information.

Registrant Reference Number: 070063494

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Rd. 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.

22-JUN-07

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

22-JUN-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. 2724404

Product Name: Vet Kem Ovitrol Plus Flea Tick and Bot Spray

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .27 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .62 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .37 %
  • PYRETHRINS
    • Guarantee/concentration .2 %

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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 June 21, 2007, at 10:00 am the owner took his two 5-7 week old, male, intact, Domestic Shorthair, kittens to his regular veterinarian. The veterinarian treated the kittens with the product that morning and sent the owner home with antibiotics for a respiratory infection. The owner applied the product again that evening at 11:00 pm, CDT. The owner was using this product to treat a flea infestation.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

1

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

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non rétabli

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

At 12:05 am, CDT on June 22, 2007 the 7 week old kitten began to have seizures. The APSS veterinarian recommended that the owner take the kitten to a veterinarian to be treated and given supportive care. On June 24, the owner informed the APSS staff that on June 22, 2007 the kitten passed away when the owner arrived at the emergency clinic.

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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 explained to the owner that the kitten may well be anemic from heavy flea burden, which can become a problem if kitten is suddenly stressed. The APSS staff recommended that a necropsy be performed on the kitten, but the owner informed the APSS staff member that the kitten had been buried at the clinic. The product was not used according to label directions. Minimum age is 12 weeks. Kitten was 7 weeks old. Label states reapplication weekly if necessary. Product was applied twice in one day - over application of product. APSS veterinarian stated the product is relatively safe, even in an off-label manner as in this case. APSS veterinarian further stated the product was considered to have low likelihood of causing the clinical situation.