Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4845

2. Registrant Information.

Registrant Reference Number: 2023-CA-000204

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.

09-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-JUN-23

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)
  • (S)-METHOPRENE
  • PERMETHRIN

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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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriver

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

43.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Vocalizing
  • Symptom - Abnormal behaviour

• Skin
  • Symptom - Hair loss
  • Symptom - Lesion
  • Specify - Ulceration

• General
  • Symptom - Other
  • Specify - Unspecified symptoms

• Skin
  • Symptom - Blister
  • Specify - Bubbling of skin
  • Symptom - Dermatitis

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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 07 Jun 2023, the animal owner applied the product topically to the dog. Approximately 3-4 hours later, the dog developed hair loss at the application site. On 09 Jun 2023, The dog developed an area of approximately 6 inches x 6 inches of hair loss and the underlying skin was raw, ulcerated. and some skin was missing. The dog was rolling on the floor (abnormal behaviour) and whining (vocalization). During a separate report the animal owner reported that on an unspecified date the dog developed hair loss and bubbling of the skin at the site of product application. Method of determining the clinical status was not provided. 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 and severe symptoms reported are not expected following use. Mild dermal irritation is possible following topical use. Individual sensitivities may occur and result in more significant dermal irritation. Further description of the clinical signs leading the animal owner to report the dog was dying were not provided and can not be assessed. Veterinary examination and diagnostics may have been able to provide further information about the cause of the clinical signs, but these were not reported. 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.