Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0211

2. Registrant Information.

Registrant Reference Number: 120124870

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.

05-SEP-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-SEP-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).

On September 2, 2012 the owner applied the product to the dog to treat for fleas.

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

Bichon Frise Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Hyperactivity

• Nervous and Muscular Systems
  • Symptom - Restlessness

• General
  • Symptom - Vocalizing
  • Symptom - Pacing

• Skin
  • Symptom - Erythema

12. How long did the symptoms last?

<=30 min / <=30 min

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

On September 2, 2012 the owner noticed that the dog was symptomatic. About 15 minutes later, the owner bathed the dog with his regular dog shampoo and conditioner, and a short time later the owner noticed that the dog had fully recovered. On September 5, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help and to see if she could use a different flea product on her dog so soon after applying the Zodiac product. The APSS veterinarian stated that the dog's signs were consistent with hyperesthesia and were expected to be self-limiting. The APSS assistant said it was okay for the owner to use a different flea product with a different insecticide. The APSS assistant also recommended that the owner monitor the dog at home 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

Minor

19. Provide supplemental information here