Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-5888

2. Registrant Information.

Registrant Reference Number: 2021-CA-000036

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.

04-MAR-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-MAR-21

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. 31368      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Smart Shield Flea Control for Cats and Kittens

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

Unknown

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

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Aggressive behaviour

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Abnormal behaviour
  • Specify - Running away

12. How long did the symptoms last?

Unknown / Inconnu

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

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 03 March 2021 the animal owner applied the product topically to the cat. Immediately after application the cat developed aggressive behaviour. The cat then ran away from the animal owners and went into the basement; the cat was confined in the basement overnight. On the morning of 04 March 2021 the cat was released from the basement and the cat developed application site pruritus as well as aggressive behaviour. Cat was confined to the basement again. Bathing the cat was discussed with the animal owner, but only if it could be performed with no risk of injury to people or the cat. 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

(S)-Methoprene and the other ingredients in this product have a wide margin of safety. There is risk of irritation including dermal, ocular (if ocular contact had occurred), and GI (if ingested). Pruritus may occur due to dermal irritation or because of the presence of fleas. Discomfort may develop when dermal irritation occurs and some cats could manifest this discomfort as aggression, however direct development of aggression due to this products use is not expected. Hiding behaviour may also be a manifestation of discomfort due to dermal irritation. Other causes including stress during handling for product application, trauma, or underlying causes should also be considered. 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.