Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6374

2. Registrant Information.

Registrant Reference Number: 2022-CA-000413

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.

23-SEP-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-JUL-22

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea and Tick Control for Dogs Over 14kg

• Active Ingredient(s)
  • PERMETHRIN
  • S-METHOPRENE

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

Units: mL

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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

54.4

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

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

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Fully Recovered / Complètement rétabli

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 11 Jul 2022 the animal owner applied the product to the dog topically. On 12 Jul 2022, the dog developed a single seizure lasting 5-10 seconds. On 28 Aug 2022, the dog developed a seizure lasting 5-10 seconds. On 11 Sep 2022, the dog developed a seizure lasting 5-10 seconds. On 22 Sep 2022, the dog developed three seizures lasting 5-10 seconds each. Veterinary evaluation was recommended. No treatments had been provided.

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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 exposure. Individual sensitivities may occur. There is a temporal relationship between product use and initial onset of clinical signs. Delayed seizure activity for several months following product use is not expected. Other causes of the clinical signs remain in consideration including other ongoing product exposures and underlying disease. 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.