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: 2015-7170

2. Registrant Information.

Registrant Reference Number: 150136968

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.

04-OCT-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-OCT-15

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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • 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: Other / Autre

Préciser le type: Relay

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On September 28, 2015 a female dog was bathed with this product and gave birth to a litter of 12 puppies on September 30, 2015. Unknown if veterinarian consulted for use on pregnant dog.

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

Irish Wolfhound

4. Number of animals affected

3

5. Sex

Unknown

6. Age (provide a range if necessary )

0.011

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

Oral

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

  • General
    • Symptom - Death

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

Died

16. How was the animal exposed?

Other / Autre

specify Relay

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On October 2, 2015 three of the puppies died. On October 4, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated shampoos have low residual activity, and would not pose a risk to the puppies, especially if the dams were rinsed really well. The APSS veterinarian also stated she would be more suspicious of 'fading puppy syndrome', of which the exact cause is often hard to determine. The APSS assistant recommended calling back with questions and a necropsy (which was not available).


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A follow up was not performed, because the product was not related. Unknown if veterinarian was consulted for use on pregnant dog.