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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0006

2. Registrant Information.

Registrant Reference Number: 110046322

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.

19-APR-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-APR-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.

.5

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 April 18, 2011 the owner applied the product to her dog.

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

Female

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

6.0

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Erythema

12. How long did the symptoms last?

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

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

Yes

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 April 18, 2011 the owner noticed her dog was symptomatic. She immediately bathed the dog, and she bathed the dog again later that evening and a third time on the morning of April 19, 2011. On April 19, 2011 the owner noticed that the dog's symptoms had worsened. The owner took the dog to the veterinarian, where dexamethasone and prednisone were administered to the dog. Shortly after taking the dog to the veterinarian, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that local dermal irritation, itching, and redness can be seen when some sensitive animals are exposed to the product. The APSS assistant recommended providing the dog with vitamin E and diphenhydramine, monitoring the dog at home, calling back with questions, and contacting the manufacturer for refund information.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On April 26, 2011 an APSS assistant contacted the owner to update the case. The owner stated that the dog was fully recovered by April 20, 2011, approximately 48 hours after being exposed to the product.