Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0042

2. Registrant Information.

Registrant Reference Number: 080141015

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.

18-DEC-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-DEC-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. 23075      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Premise Plus Flea Spray

• 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.

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).

Between December 3, 2008 and December 17, 2008, the owner inappropriately applied the Premise product to her dog three times.

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

Dog / Chien

3. Breed

Shih Tzu Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.17

7. Weight (provide a range if necessary )

13.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Restlessness

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

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

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

On December 16, 2008, the owners gave the dog a bath. The owners took the pet to the veterinarian on December 18, where the regular veterinarian gave sucralfate. The APSS veterinarian recommended the clinic monitor for dermatological signs, provide symptomatic and supportive care, provide appropriate flea treatment, give a bath with a mild liquid dish washing detergent, manage vomiting, and apply vitamin E to inflamed skin.

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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

Clinic stated that the pet was treated as an outpatient and the final outcome was unknown. Off label use: Do not treat pets with this product.