Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2594

2. Registrant Information.

Registrant Reference Number: 090063907

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.

10-JUN-09

5. Location of incident.

Country: UNITED STATES

Prov / State: IOWA

6. Date incident was first observed.

10-JUN-09

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. 2724-404

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 10, 2009, the veterinarian and veterinary staff applied the product to the under aged kitten to treat external parasites.

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

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 )

0.01

7. Weight (provide a range if necessary )

1.2

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hypothermia

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Mental Dullness
  • Symptom - Other
  • Specify - Star Gazing

• General
  • Symptom - Weakness
  • Specify - Flaccid

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Difficulty swallowing

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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

The owner took the kitten to the veterinarian. The veterinarian found the kitten to be hypothermic with a temperature of 96 degrees Fahrenheit. The veterinarian bathed the kitten, placed him in an oxygen cage, provided thermoregulation, and gave oral dextrose and subcutaneous fluids. The APSS veterinarian recommended that the veterinarian continue providing thermoregulation, monitor the kitten's blood glucose, offer symptomatic and supportive care, and run a complete blood count (CBC). APSS also recommended a necropsy if the kitten died. Kitten also had intestinal parasites, ring worm, and ear mites and lice. Other treatments included tresaderm, albon and panacur.

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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 veterinarian stated that the owner declined all recommended treatment and called later on June 10, 2009 to inform them that the kitten died. A necropsy was not done because the body was not available. This was off label use.