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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5609

2. Registrant Information.

Registrant Reference Number: 2020-US-031683

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.

01-SEP-20

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-734-89459

Product Name: Four Paws Elite Aloe Ear Mite Treatment for Cats

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .05 %

7. b) Type of formulation.

Liquid

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

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

4.989

kg

8. Route(s) of exposure

Unknown

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

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Bizarre behaviour
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Unknown

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

The animal owner applied the product to the cat for 5 days starting on an unknown date. After 3 days the cat developed anorexia and bizarre behaviour. The cat was evaluated by a veterinarian on an unknown date, unknown if treatments were performed, and the cat died 30 minutes after veterinary evaluation. According to the animal owner, their veterinarian thought the cat's signs were due to an allergic reaction. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: This product has a wide margin of safety. If ingested, mild GI upset such as anorexia is possible. Otic irritation may occur from product application. With inner ear irritation, ruptured eardrums, underlying ear mites, or diseases such as vestibular disease there is the potential for symptoms such as balance issues, head tilt, and behavioural changes such as hiding to develop. Death is not expected. Allergic reactions that result in death typically cause severe rapid onset of symptoms rather than the minor and moderate signs described. Further information from the treating veterinarian could have provided additional information about the cat's clinical signs, possible causes, and death. Necropsy may have also provided additional information but was not pursued. Other causes for the cat's death should be considered including infection, trauma, and underlying disease. The information contained in this report is based on self-reported statements provided to the registrant during email and 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.