Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6370

2. Registrant Information.

Registrant Reference Number: 2022-CA-000358

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.

26-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-AUG-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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray for Dogs and Cats, 475 mL

• Active Ingredient(s)
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS
  • S-METHOPRENE

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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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

3.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Adipsia
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Abnormal posture
  • Specify - Unable to raise head
  • Symptom - Staggering

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 23 Aug 2022, the animal owner applied a couple of sprays of the product topically to the dog. The dog did not ingest any of the product. Approximately 1 hour post application the dog developed a loss of appetite, not wanting to drink (adipsia), lethargy, and vomiting. On 26 Aug 2022, the dog developed an inability to raise their head and staggering. On 26 Aug 2022, the dog was examined by a veterinarian and hospitalized. Patient remained hospitalized on 29 Aug 2022. No information regarding examination findings, treatments, or diagnostics was provided. No further information was received.

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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. If ingested, mild self-limiting GI irritation may occur including transient vomiting or inappetence. The severity and persistence of clinical signs reported in this case is not expected. There is a temporal relationship between product use and onset of clinical signs. Further information including veterinary examination, diagnostics, and response to treatment may have been able to provide further insight about the cause of this dogs clinical signs; however, these were not available. Other causes of the clinical signs remain in consideration including toxin exposure, trauma, infection, 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.