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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0201

2. Registrant Information.

Registrant Reference Number: 150156352

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.

12-NOV-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 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

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 an unknown date the owner applied the product onto the cat as prevention.

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

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling

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

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 November 12, 2015 the company assistant started a case based on an email received by the owner on October 28, 2015. The owner stated the cat developed hypersalivation within a minute of application of the product. The owner also stated she had bathed the cat and at the time of the email, the cat had fully recovered. The owner did not provide the date of treatment, onset, duration of symptoms, or when the bath was provided. The company assistant stated hypersalivation can occur after the topical application of any flea and tick product to a cat; symptoms expected to be mild and self limited.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

No significant signs were expected.