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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0475

2. Registrant Information.

Registrant Reference Number: 070062360

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.

19-JUN-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-JUN-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodaic Fleatrol Double Action Flea + Tick Shampoo

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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 June 18, 2007 at 7:00 p.m. CDT, the owner applied an unknown amount of this product to his 1 year old, intact, male, domestic short hair cat. The product was applied at the owner's home, and it was used appropriately to prevent fleas and ticks.

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

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Drooling

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?

No

14. b) How long was the animal hospitalized?

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 19, 2007, the owner noticed the patient was foaming at the mouth, so the owner bathed the cat with baby shampoo. The drooling stopped after the bath, but it began again. The owner bathed the cat again, but the drooling continued. At 5:30 a.m. CDT, the owner took the cat to the emergency veterinary clinic. However, he could not afford treatment, so he took the cat back home. At the time of contact with the Animal Product Safety Service (APSS) staff at 12:37 p.m. CDT on June 19, 2007, the owner had recently bathed the cat with liquid dish washing detergent. The APSS staff suggested that significant signs are not typical for an exposure to this product and suggested the cat may be trembling because of a temperature decrease.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The Animal Product Safety Service (APSS) staff recommended the owner feed the cat a taste treat to help eliminate the product taste from the cat's mouth, keep the cat warm and quiet, and monitor the him at home. If signs continue, the APSS staff recommended the owner take the cat to his regular veterinarian and call back with questions. No significant signs were expected from this exposure, so no follow up was scheduled.