Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4503

2. Registrant Information.

Registrant Reference Number: 190106629

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: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

20-JUN-19

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

20-JUN-19

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 With 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).

On June 18, 2019, the owner applied this product to the cat. The owner had applied the product from the same box before with no signs seen.

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

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• Renal System
  • Symptom - Urinary incontinence

• Skin
  • Symptom - Irritated skin
  • Specify - Application Site Irritation

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

Not recovered / Non 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 June 20, 2019, the cat had a seizure and an isolated event of urinary incontinence. Two hours later, the owner bathed the cat. Three hours later, the owner took the cat to their regular veterinarian, who provided fluids and supportive care. The regular veterinarian also noticed that the cat had developed an application site irritation. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that s-methoprene is an insect growth regulator (IGR) and that the primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian also stated that if ingested, mild tremors within hours of application are rarely seen. The APSS assistant recommended the owner have the veterinarian call for information.

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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

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On June 24, 2019, an APSS technician called to follow up on the case. The owner stated that the cat's seizure resolved on June 24, 2019. The owner also stated that the cat was at home and doing much better after receiving fluids at the regular veterinary clinic for a few days.