Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6436

2. Registrant Information.

Registrant Reference Number: 2021-US-048805

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.

28-OCT-21

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

14-OCT-21

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.       PMRA Submission No.       EPA Registration No. 2724-803-270

Product Name: Adams Flea and Tick Spray for Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .1 %
  • ETOFENPROX
    • Guarantee/concentration .25 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .75 %

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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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Other / Autre

specify Hamster

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

190

g

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

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

11. List all symptoms

System

• 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

On the evening of 13 Oct 2021 the animal owner applied one spray of the product to the hamster. On 14 Oct 2021, the hamster develop seizures. On an unspecified date, the hamster died. 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

Death

19. Provide supplemental information here

Assessment: Off label use. This product has a wide margin of safety and neither seizures nor death are expected with labelled use. Use of this product on hamsters is extra label use; however, severe adverse effects would not be expected in hamsters from use as in this case. Other causes for the clinical signs should be considered including trauma, infection, and exposure to other products. 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.