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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5604

2. Registrant Information.

Registrant Reference Number: 2020-US-028016

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.

12-AUG-20

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

08-AUG-20

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. 2724-627

Product Name: Zodiac Flea and Tick Powder for Dogs, Puppies, Cats and Kittens

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1 %
    • PYRETHRINS
      • Guarantee/concentration .1 %

7. b) Type of formulation.

Dust

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?

No

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

4

5. Sex

Female

6. Age (provide a range if necessary )

0.15

7. Weight (provide a range if necessary )

2.268

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Urinary incontinence
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

Animal owner applied the product topically to the kitten on 8-Aug-2020. Immediately after application the kitten developed adipsia, anorexia, and lethargy. On 9-Aug-2020 the kitten developed a seizure and urinary incontinence. The kitten died on 9-Aug-2020. Necropsy was not performed. Veterinary care was not sought for any of the cats. 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. Neither neurological signs such as urinary incontinence and seizures nor death are expected, even with off labelled use as in this case. Other causes for the symptoms should be considered including exposure to other insecticides including ones containing higher concentrations of pyrethroids including permethrin intended for canine use, flea infestation leading to flea bite anemia, infectious disease, and underlying health conditions. Veterinary examination and diagnostics including necropsy may have been able to provide further information about the cause of the clinical signs and death, but these were not pursued. 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.