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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0077

2. Registrant Information.

Registrant Reference Number: 150003365

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.

08-JAN-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

23-JUL-14

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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Spray For Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • 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).

On July 15, 2014 the owner sprayed the dog and again on July 22, 2014.

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

Golden Retriever Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11.5

7. Weight (provide a range if necessary )

80.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom -
    • Symptom - Pruritus
    • Symptom - Hair loss
    • Symptom - Other
    • Specify - Foul Skin Odor

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 July 23, 2014 the dog developed symptoms. On January 8, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated there is a low risk for mild irritation if sprayed heavily. The APSS veterinarian stated product carries would evaporate within a short time and pyrethrins will break down within a couple weeks of application. The APSS technician recommended taking the dog to the veterinarian (for diagnostics - skin scrapings to assess for yeast and mites) and calling back with questions. The owner described the dog as smelling yeasty and he had not taken the dog back to the veterinarian because he lost confidence in him. The owner stated the dog had a flea infestation along with a yeast and bacterial infection. The owner stated the veterinarian recommended using the product. The owner stated it was after the second application of the product that the signs started and still continue.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. The APSS veterinarian stated that malessezia dermatitis was considered to have an unknown likelihood of causing the clinical situation. The APSS veterinarian stated that atopic dermatitis was considered to have an unknown likelihood of causing the clinical situation.