Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7195

2. Registrant Information.

Registrant Reference Number: 130060012

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-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

03-APR-13

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.       PMRA Submission No.       EPA Registration No. 2724-815

Product Name: Kirkland Signature Flea And Tick Control For Medium Dogs 13 to 31 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • ETOFENPROX
    • PIPERONYL BUTOXIDE

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-814

Product Name: Kirkland Signature Flea And Tick Control For Cats 5lbs and over

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

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 April 3, 2013 the owner applied 1.8 milliliters (mL) of the cat product to the cat to prevent fleas; the cat was able to lick some of the product. On April 6, 2013 the owner applied 3.0 mL of the dog product to the dog to prevent fleas. Unknown if owner consulted veterinarian prior to use on dog due to dogs medical issues.

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

American Eskimo

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

19.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure

12. How long did the symptoms last?

<=30 min / <=30 min

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

On April 8, 2013 the owner noticed that the dog was symptomatic. The owner immediately took the dog to the Emergency veterinarian, where the dog was given fluid therapy and Diazepam. Again on May 3, 2013 the owner took the dog to the veterinarian. Later that evening the owner noticed that the dog had another seizure, which was more severe than the first episode. The owner treated the dog at home with Diazepam and the dog recovered a short time later. On May 8, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that labeled use of the product is considered safe and the dog's seizure activity would not be expected to be related to the product. The APSS assistant recommended that the owner have her veterinarian call for information.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13.0

7. Weight (provide a range if necessary )

13.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change

12. How long did the symptoms last?

Unknown / Inconnu

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

No

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 3, 2013 the owner noticed that the cat was vocalizing and experiencing a behavior change, rolling around and trying to lick her back. Later that evening the owner bathed the cat, and a short time later that evening the cat fully recovered. On May 8, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the labeled application of the product is considered safe and that the cat's signs may reflect the personality of some cats that can be somewhat uncomfortable (transiently) having topical flea control agents applied in a labeled manner. The APSS assistant told the owner that no treatment was necessary.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs are expected to be mild and self limiting. Product not registered in Canada