Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4451

2. Registrant Information.

Registrant Reference Number: 080099098

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.

04-SEP-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-SEP-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Double Action Flea And Tick Shampoo

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

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 September 4, 2008, the owner applied the product to his 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair Cat

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Recumbent
  • Symptom - Unresponsive

• General
  • Symptom - Hypothermia

• Cardiovascular System
  • Symptom - Bradycardia

• Nervous and Muscular Systems
  • Symptom - Disorientation

• General
  • Symptom - Vocalizing
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 Animal Product Safety Service technician recommended that the owner take his cat to an emergency veterinarian and have the emergency veterinarian call for information. Later on September 4, the emergency veterinarian called back to update the case. Upon arrival to the emergency clinic, the pet was unresponsive, hypothermic, and had a decreased heart rate. The cat died within five minutes of arrival at the hospital. The APSS technician recommended a necropsy, but the body had already been cremated.

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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

According to the veterinarian at APSS, the product was not related to the clinical situation.