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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0078

2. Registrant Information.

Registrant Reference Number: 100049790

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.


5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.


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.


PMRA Registration No. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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 12, 2010 the owner applied the product to the dog for prevention.

To be determined by Registrant

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


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms


  • General
    • Symptom - Polydipsia
  • Nervous and Muscular Systems
    • Symptom - Head shaking
  • Skin
    • Symptom - Itchy skin
    • Symptom - Other
    • Specify - Warm skin
    • Symptom - Dermatitis
    • Specify - Acute Moist Dermatitis

12. How long did the symptoms last?

Unknown / Inconnu

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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, 2010 the owner noticed the dog was very thirsty. On April 19, 2010 the owner noticed the dog was shaking his head, scratching at the application site, felt warm to the touch, and had a hot spot on the left side of his face. On April 21, 2010 the owner took the dog to the veterinarian, where the attending veterinarian prescribed Clavaseptin, Prednisone, and Topagen. On April, 2010 the APSS veterinarian stated dogs tolerate pyrethroids well and no life threatening signs are expected. The APSS veterinarian also stated that pyrethroids can cause a pins and needles sensation or hyperesthesia. The APSS veterinarian recommended monitoring the dog at home, calling back with questions, calling the veterinarian to discuss alternative flea preventions, and calling the manufacturer to discuss his reimbursement concerns.

To be determined by Registrant

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


19. Provide supplemental information here

On April 26, 2010 the owner called the APSS to return our follow up call. The owner stated the dog had improved, but is not back to normal yet. He also stated he is still giving the dog the medications and will continue doing so for a week, then go back to the attending veterinarian for a recheck.