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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7157

2. Registrant Information.

Registrant Reference Number: 130001067

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.

03-JAN-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Sometime between August 16 and August 30, 2012 the owner bathed the dog with the flea and tick shampoo product to treat for fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

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 )

7.0

7. Weight (provide a range if necessary )

5.8

kg

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 - Pruritus

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

Sometime between August 21 and August 29, 2012 the owner noticed that the dog was symptomatic. On August 29, 2012 the owner took the dog to the veterinarian, where the dog was given prednisone and dexamethasone injections. Later on the evening of August 29, 2012 the owner observed that the dog had fully recovered. On January 3, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that no signs would be expected with appropriate use of the flea and tick shampoo product. The APSS assistant recommended that the owner monitor the dog at home, call back with questions, and consult with a veterinarian about appropriate flea prevention methods and shampoo products to use on the dog.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Signs were expected to be mild and self limiting.