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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-1160

2. Registrant Information.

Registrant Reference Number: 070119739

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.

14-NOV-07

5. Location of incident.

Country: UNITED STATES

Prov / State: IOWA

6. Date incident was first observed.

11-NOV-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.       PMRA Submission No.       EPA Registration No. 2724-488

Product Name: Zodiac Fleatrol Spot On Special Formula for Cats and Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %

7. b) Type of formulation.

Liquid

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 November 11, 2007 the owner applied the product to her cat as a form of treatment.

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 )

1

7. Weight (provide a range if necessary )

5.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Weakness
    • Symptom - Abnormal behaviour
    • Specify - Personality changes
  • Blood
    • Symptom - Hyperbilirubinemia
    • Specify - Hyperbilirubinemia
  • Liver
    • Symptom - Hepatic failure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 14, 2007 the owner took the animal into a local veterinary clinic where the cat received fluids. The APSS staff member stated that the product has a very wide margin of safety. The signs the animal was displaying were much more severe than what would be expected after use of the product. The APSS veterinarian recommended the attending veterinarian contact the APSS to discuss treatment recommendations.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian doubted this substance was related to causing the clinical situation. On November 19, 2007 the owner contacted the APSS to update the case. The owner stated her animal passed on November 15, 2007 after being diagnosed with hyperbilirubinemia and hepatic failure. The owner declined the recommended necropsy, stating the animal was already buried.