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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0011

2. Registrant Information.

Registrant Reference Number: 110064694

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.

27-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

26-MAY-11

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)

PMRA Registration No. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg (30 lbs)

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

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 May 26, 2011 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

Miniature Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Dermatitis
  • General
    • Symptom - Lethargy

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 May 26, 2011 shortly after the product was applied, the owner noticed the dog was agitated, which resolved soon after. On May 28, 2011 the owner noticed the dog had developed moist dermatitis at the site of application, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated permethrins can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus and occasionally animals will develop sores or scabs, and alopecia. The APSS veterinarian also stated some animals are more sensitive to the ingredient than others. She further stated signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-48 hours. The APSS technician relayed the APSS veterinarian's recommendations to bathe the dog with liquid dish washing detergent (LDWD), apply Vitamin E and a cold compress to the application site, take the dog to the veterinarian if at any point appears to worsening or become purulent, call back with questions, and refer to the manufacturer for reimbursement information.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

Signs expected to be mild and self limiting.