Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6380

2. Registrant Information.

Registrant Reference Number: 2022-CA-000323

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.

05-AUG-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)

---

PMRA Registration No. 31366      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot w Smart Shield Flea and Tick Control for Dogs 14+kg

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

---

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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

33

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

• Renal System
  • Symptom - Inappropriate urination

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Symptom - Anxiety
  • Symptom - Muscle weakness
  • Symptom - Abnormal gait
  • Symptom - Paresis

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

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 12 Jul 2022, the animal owner applied the product topically. Within 10 hours following product use, the dog urinated inappropriately. Approximately 10 hours following product use the dog lost partial use of his rear limbs (paresis), had difficulty walking, and an abnormal gait. On approximately 13 Jul 2022, the dog developed anxiety around stairs. The dog was bathed with dog shampoo and water. The dog was brought to a veterinary hospital for examination and treatment approximately 24 hours after product use and was prescribed robenacoxib to be given once daily for 4 days and gabapentin to be given twice daily for 7 days. On approximately 15 Jul 2022 the dogs clinical signs improved. On approximately 05 Aug 2022, the abnormal gait and weakness persisted but were improved. On approximately 06 Aug 2022, the clinical signs resolved. The dog has a history of seizures and thyroid disease; the dog is on phenobarbital and levothyroxine supplementation. No further information is expected. It is unknown if the veterinarian was consulted before using the product on the geriatric dog that had health conditions.

---

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 and paresthesia are possible following topical use. If ingested, mild self-limiting GI irritation leading to increased salivation and vomiting may occur. Neurological signs such as those described are not expected. Further information about physical exam findings and diagnostics may provide further insight about the cause of this dogs clinical signs; however, these were not available. Other causes for the clinical signs such as the underlying neurological disease remain in strong consideration. 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.