Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0067

2. Registrant Information.

Registrant Reference Number: 090035237

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.

03-APR-09

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

02-APR-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. 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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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

Units: mL

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 April 2, 2009, the owner applied the product to the pet to treat a flea infestation.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

27.5

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 - Hiding
  • Symptom - Restlessness
  • Symptom - Abnormal behaviour
  • Specify - Circling

• Skin
  • Symptom - Erythema

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• 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

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

The APASS technician recommended bathing the dog with liquid dish soap, applying vitamin E to the affected area once or twice daily, and giving diphenhydramine twice daily as needed. She also recommended taking the dog to the veterinarian and having the veterinarian call for information if home care did not help.

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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 owner applied vitamin E and gave diphenhydramine on April 6, 2009. He also took the dog to the vet and had the vet call for information. The following signs ended on April 6, 2009: hiding, restlessness, circling, and tremors. The erythema and alopecia were still present at the time of the call. The owner stated that on April 7, 2009, the dog was dysuric and had discolored urine. The APSS veterinarian recommended that he take the dog to the veterinarian for evaluation of his urinary signs. The APSS veterinarian stated that the signs the dog is displaying would not be related to the use of the product. It is not known if the proper size product was used because the dog's weight is unclear.