Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6405

2. Registrant Information.

Registrant Reference Number: 2021-CA-000191 and 2021-CA-000192

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.

20-JUL-21

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

Unknown

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. 31984      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Infestop for Cats 4kg and Over

• Active Ingredient(s)
  • IMIDACLOPRID

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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

Cat / Chat

3. Breed

Domestic Shorthair Cat

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

4

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Symptom - Constipation

• Nervous and Muscular Systems
  • Symptom - Loss of coordination

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?

No

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 12 Jun 2021, the animal owner applied the product topically to the cat as a preventative. On 12 Jun 2021, the cat developed lethargy. On 14 Jun 2021, the lethargy resolved. On approximately 13 Jul 2021, the animal owner again applied the product topically to the cat. On approximately 15 Jul 2021, the cat developed lethargy, lack of coordination (ataxia), and loss of appetite. On approximately 15 Jul 2021, the animal owner bathed the application site with a degreasing dish soap. On 19 Jul 2021, the cat was examined and treated at a veterinary clinic; treatments included 150 mL subcutaneous fluids and 15.6 mg maropitant. Mirtazapine prescribed to be given to the cat. On 19 Jul 2021, the cat started eating. On 20 Jul the cat had a bowel movement (first since 15 Jul 2021) and ataxia improved. On 21 Jul 2021, the lethargy improved but had not resolved. No further information is expected.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Assessment: Imidacloprid and the inactive ingredients in this product have a wide margin of safety. Mild dermal irritation is possible following topical use. Some cats will respond to the act of having a topical product applied with transient minor behavioural change such as lethargy. Ataxia and loss of coordination are not expected. If ingested, mild self-limiting GI irritation may occur that can include anorexia. However, duration of anorexia is greater than would be expected. Other causes for the cats symptoms should be considered including stress secondary to application, exposure to other insecticides including ones containing permethrin that are intended for canine use, and underlying disease. Results of the veterinary examination may have been able to provide further information about the cause of the clinical signs, but these were not provided. 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.