Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7190

2. Registrant Information.

Registrant Reference Number: 130055049

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.

29-APR-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

01-DEC-12

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 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.

1

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).

Starting around November 30, 2012 owner used product and animal became symptomatic and continuing monthly until February 28, 2013, the owner applied 1.0 mL of the product to the dog to prevent fleas.

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

Dog / Chien

3. Breed

Chihuahua Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

13.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Symptom - Pruritus

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

No

14. a) Was the animal hospitalized?

No

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

Late on the evening of November 30, 2012 or on December 1, 2012 the owner observed that the dog symptomatic. The owner immediately changed the dog's diet to see if a certain type of protein was causing the hair loss and itching. Despite the continuation of signs, the owner continued to apply the product monthly. The last dose given was on February 28, 2013, and on March 1, 2013 the owner noticed that the dog had fully recovered and was starting to grow his hair back. On April 29, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that it was possible that the hair loss could result from a hypersensitivity reaction to either the active or the inert ingredients in the product. The APSS technician determined that no treatment was necessary because the dog had fully recovered and all of his hair had regrown by the time of the consultation.

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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

Not sure if veterinarian was consulted before use.