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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6867

2. Registrant Information.

Registrant Reference Number: 2019-CA-000144

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.

16-OCT-19

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

16-OCT-19

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 Cats and Dogs

  • 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: 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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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

Pit Bull, Shephard crossbreed dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.41

7. Weight (provide a range if necessary )

18.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Gagging
  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Ataxia

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 16 Oct 2019, the dog was bathed with the Zodiac Double Action Flea and Tick Shampoo for Cats and Dogs via the topical route by the animal owner. The animal owner was concerned that the dog may have also ingested some of the shampoo while being bathed. The dog was also bathed with skunk b gone, hydrogen peroxide and liquid dish soap via the topical route prior to the Zodiac Double Action Flea and Tick Shampoo for Cats and Dogs. Two weeks prior to use of the Zodiac Double Action Flea and Tick Shampoo for Cats and Dogs, the animal owner had applied topical selamectin topically to the dog. After bathing the dog, the dog developed trembling and gagging. About 90 minutes later the dog became ataxic. Veterinary care was recommended as well as further bathing with a liquid dish soap. No further information was received in this case.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Assessment: This product has a wide margin of safety when used as labeled. When ingested, there is the potential for oral and gastric irritation resulting in signs such as hypersalivation, gagging, and vomiting. Trembling can occur following bathing due to stress and coldness in addition to the unlikely event of interactions between products applied. Ataxia would not be expected from this shampoo with either topical or oral exposure in a dog. This product had been used previously with this dog on two occasions, most recently 60-90 days prior to the incident reported. No symptoms were noted with prior use of this product in this dog which supports looking for other possible causes for the clinical signs. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.