Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0274

2. Registrant Information.

Registrant Reference Number: 100133641

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.

14-OCT-10

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

11-OCT-10

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. 25920      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On Flea and Tick Control for Dogs Over 14 kg

• Active Ingredient(s)
  • 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 October 10, 2010 the owner applied the product onto the dog.

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

Dog / Chien

3. Breed

German Shepherd Dog Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

29

kg

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

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

• Blood
  • Symptom - Other
  • Specify - Azotemia

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?

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

On October 11, 2010 the dog vomited. On October 14, 2010 the owner took the dog to the veterinarian, where a chemistry profile was done. That same day, the dog vomited again, became lethargic, and was diagnosed with azotemia, so the attending veterinarian contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated may see some dermal irritation. Renal damage is not expected under any circumstances. The APSS veterinarian recommended fluid therapy, supportive care, and calling 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 substance was not considered to be related to causing the clinical situation.