Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0210

2. Registrant Information.

Registrant Reference Number: 120123140

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.

01-SEP-12

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

01-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 August 30, 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

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

3.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Stiffness

• Gastrointestinal System
  • Symptom - Drooling
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Trembling

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

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 September 1, 2012 the owner noticed that the dog was symptomatic. Later that day the owner bathed the dog. That evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that permethrin is a synthetic pyrethroid insecticide commonly used in topical flea preparations, and although there is a wide margin of safety in dogs, smaller animals may be more sensitive to permethrin. The APSS veterinarian said that bathing the animal to remove the product typically resolves the signs associated with a dermal reaction. The APSS veterinarian also said that if a small amount of the product is ingested via grooming, a taste reaction characterized by hypersalivation could occur, and this typically resolves when a taste treat is given. The APSS veterinarian continued by noting that methoprene is an insect growth regulator, and topical application of this type of product as per label directions is not expected to cause significant clinical signs. The APSS veterinarian concluded by stating that if the product is ingested via grooming, a taste reaction characterized by hypersalivation could occur and that if repeated grooming leads to repeated taste reactions, bathing the product off of the animal may be necessary. The APSS assistant recommended that the owner take the dog to the veterinarian, have the veterinarian call for information, 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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.