Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0536

2. Registrant Information.

Registrant Reference Number: 070096586

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

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

10-SEP-07

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

29-AUG-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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • 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 August 28, 2007 and August 29, 2007, the owner applied the product to her cats as a form of treatment.

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

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

12. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement 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

On the same day, the owner took the cat to the veterinarian and gave him a bath. On September 10, 2007, the APSS staff member stated that it sounded like a taste reaction to the product. Since the cat was back to normal within an hour of the exposure, the APSS staff did not recommend any additional treatment.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

Symptoms indicate taste reaction to product.

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 )

4

7. Weight (provide a range if necessary )

13

lbs

8. Route(s) of exposure

Skin

Oral

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

• Gastrointestinal System
  • Symptom - Drooling

• Skin
  • Symptom - Hair loss

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement 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

On August 29, 2007 the owner noticed that the cat was hypersalivating. The owner believes that the cat licked some of the product off of the other cat that was treated that day. The owner also stated that she took the cat to the veterinarian and gave the cat a bath on the same day of exposure. On September 3, 2007 the owner noticed that the cat was experiencing alopecia, that occurred from the animal chewing hair off his rump area. On September 10, 2007 the APSS staff member stated that the alopecia was probably due to a flea allergy, and that the owner should take the cat into the veterinarian to treat the animal for possible flea allergy dermatitis.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

The APSS staff member concluded that this product was considered to have a medium likelihood of causing the clinical situation.