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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-5995

2. Registrant Information.

Registrant Reference Number: 070043219

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Rd. West, Suite 111

City: Guelph

Prov / State: ON

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.

04-MAY-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-MAY-07

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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea And Tick Spray For Dogs And Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

PMRA Registration No. 25738      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise 1000 Flea Spray

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

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).

The owner soaked the cat with Zodiac Flea and Tick Spray For Dogs and Cats on May 3, 2007 at 5:28 p.m. CDT. The owner sprayed her dogs with the same spray. The product label states to spray until the animal is damp, but not soaked. Zodiac Premise 1000 Flea Spray was also sprayed in the house. The cat was not in the house while the owner sprayed, but the cat was in the house before the spray had dried completely. The cat was exposed to the premise spray on May 3, 2007 at 2:00 p.m. CDT.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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 )

2

7. Weight (provide a range if necessary )

2.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Seizure

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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?

2

Day(s) / Jour(s)

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

The cat had an episode of vomiting on May 4, 2007 at 6:28 a.m. CDT. Tremors and seizures were also noted on the same day at the same time. The seizures resolved later that morning at 11:29 a.m. CDT. The tremors resolved at 3:00 p.m. CDT. The cat was taken to the veterinarian for overnight care. The cat was provided with fluid therapy and was given a decontaminating bath. The Animal Product Safety Service veterinarian advised that diazepam and/or methocarbamol may need to be given to control the cat's tremors and seizures. However these medications were not required, as the cat recovered without these treatments.


To be determined by Registrant

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

Major

19. Provide supplemental information here

Zodiac Flea and Tick Spray had a low likelihood of causing the clinical situation in the cat. The Animal Product Safety Service veterinarian stated the cat was soaked with the product therefore the product was not used according to label directions. The Animal Product Safety Service veterinarian stated that the Zodiac Premise 1000 Flea Spray had a doubtful likelihood of causing the clinical situation.