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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6230

2. Registrant Information.

Registrant Reference Number: 140036533

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.

28-MAR-14

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

28-MAR-14

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. 28743      PMRA Submission No.       EPA Registration No.

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

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

PMRA Registration No. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Breakaway Flea and Tick Collar for Cats

  • Active Ingredient(s)
    • PROPOXUR

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 March 28, 2014 the owner applied 1.0 mL of the Zodiac Spot On and 1.0 Zodiac collar onto the cat.

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 )

2.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • Nervous and Muscular Systems
    • Symptom - Fasciculations

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 March 28, 2014 shortly after both products were applied to the cat, the owner noticed the cat developed symptoms. The owner then rinsed the cat and removed the collar before calling the Animal Product Safety Service (APSS). The APSS veterinarian stated with the spot on the scent or taste of the agent may cause foaming, drooling, and retching. The APSS veterinarian stated with the collar may see reaction to wearing a collar and some animals are sensitive to the plastic base. The APSS veterinarian also stated with the collar the scent or taste of propoxur may cause drooling, foaming, and retching. The APSS assistant recommended resuming therapy by leaving the collar out for 12 hours and reapplying if they would like, but would offer heavily scented food when reapplying the collar. The APSS assistant also provided information on when applying a topical next month to take the collar off first and leave it off for a few days after application. The APSS assistant further recommended monitoring the cat at home and calling back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Signs were expected to be mild and self-limiting.