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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7296

2. Registrant Information.

Registrant Reference Number: 130144218

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.

15-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

15-OCT-13

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

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 October 15, 2013 the owner applied the product to the cat to treat for fleas; the cat may have been able to lick some of the product.

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

Medical Professional

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 )

1.25

7. Weight (provide a range if necessary )

3.1

kg

8. Route(s) of exposure

Skin

Oral

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
    • Symptom - Vomiting
  • Cardiovascular System
    • Symptom - Tachycardia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 October 15, 2013 the owner noticed that the cat was symptomatic. Later that morning the owner took the cat to the veterinarian, where it was observed that the cat was tachycardic with a heart rate measured as 200.0 beats per minute (bpm). A short time later the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the cat's signs were consistent with a taste reaction and were expected to be self-limiting. The APSS veterinarian recommended that the owner's regular veterinarian bathe the cat if the product had been applied in an area where the cat could groom it off, provide symptomatic care, provide a flea treatment that kills both fleas and eggs, and have the owner decontaminate the environment.


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.