Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0770

2. Registrant Information.

Registrant Reference Number: 2022-CA-000437

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: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

14-OCT-22

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

Unknown

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)

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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)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS
  • S-METHOPRENE

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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

Cat / Chat

3. Breed

Domestic Mediumhair cat

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

4.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Eye
  • Symptom - Pupil dilation

• Nervous and Muscular Systems
  • Symptom - Shaking
  • Symptom - Trembling
  • Symptom - Abnormal gait
  • Symptom - Ataxia

12. How long did the symptoms last?

Unknown / Inconnu

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?

2

Day(s) / Jour(s)

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 08 Oct 2022, the animal owner bathed the cat with the product as per labelled instructions. At an unknown time following product use, the cat developed foaming at the mouth pupil dilation, shaking, trembling, abnormal gait (abnormally striking paws against the floor), and ataxia. On 12Oct2022, the cat was brought to a veterinary clinic where the cat was bathed, and further unspecified treatments administered. On 14Oct2022, the cat's clinical signs had improved but trembling persisted. On 14 Oct 2022, the cat was discharged from the animal hospital. No further information is expected.

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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. Mild dermal irritation is possible following topical use. If ingested, mild self-limiting GI irritation may occur which can include foaming at the mouth. Neurological involvement is not expected. Other causes exposure to higher concentration pyrethroid products intended for use on dogs as well as underlying disease remain in strong consideration. Further information including veterinary evaluation, treatments, and response to treatments may have enabled further assessment of causality; however, this information was not provided by the reporter. 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.