Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-5771

2. Registrant Information.

Registrant Reference Number: 080093138

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.

21-AUG-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-AUG-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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs over 14 kg

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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PMRA Registration No. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On Flea Control For Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE

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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 20, 2008 the owner applied the permethrin based product to both of his cats. On August 21, 2008, the owner applied the (S)-methoprene based product to both his cats.

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 Longhair Cat

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

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 - Hallucination
  • Symptom - Agitation

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

Unknown/Inconnu

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 APSS veterinarian recommended that both cats be given a bath and be thermoregulated after the bath with warm towels. The APSS veterinarian also recommended that the owner take the cats the veterinarian if tremors, ataxia, anorexia, or seizures occur, obtain additional information regarding the feline product information and the cats' statuses, and call back with questions.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the permethrin based product was considered to have a medium likelihood of causing the clinical situation and the (S)-methoprene based product had a doubtful likelihood of causing the clinical situation. Upon follow up, the owner stated that both his cats fully recovered the same day as the call into the APSS, August 21. This product was not used according to label directions, do not use on cats.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair Cat

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

10

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

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 - Agitation
  • Symptom - Hallucination

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

Unknown/Inconnu

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 APSS veterinarian recommended that both cats be given a bath and be thermoregulated after the bath with warm towels. The APSS veterinarian also recommended that the owner take the cats the veterinarian if tremors, ataxia, anorexia, or seizures occur, obtain additional information regarding the feline product information and the cats' statuses, and call back with questions.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the permethrin based product was considered to have a medium likelihood of causing the clinical situation and the (S)-methoprene based product had a doubtful likelihood of causing the clinical situation. Upon follow up, the owner stated that both his cats fully recovered the same day as the call into the APSS, August 21. This product was not used according to label directions, do not use on cats.