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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2010-5273

2. Registrant Information.

Registrant Reference Number: 100124423

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.

23-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-SEP-10

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 September 20, 2010 the owner applied the product 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

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

11

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Collapse
    • Symptom - Trembling
  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Renal System
    • Symptom - Other
    • Specify - urolithiasis blockage
  • Cardiovascular System
    • Symptom - Other
    • Specify - Congestion Heart Failure

12. How long did the symptoms last?

Persisted until death

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

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 September 20, 2010 the cat began hiding shortly after the product was applied. On September 21, 2010 the owner found the cat with symptoms, so the owner bathed the cat with liquid dish washing detergent. On September 23, 2010 the owner found the cat dead, so she contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended the owner take the cat's body to the veterinarian to have a necropsy done, having the veterinarian call for information, and hair testing if no obvious cause of death can be obtained from the necropsy.


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 stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 23, 2010 the attending veterinary technician called the APSS for instructions on how to submit the cat's body for necropsy. On September 24, 2010 the diagnostic laboratory staff called the APSS to obtain specifics on the case. The APSS veterinarian also discussed hair testing with the diagnostic laboratory staff member. On October 1, 2010 an APSS assistant called the diagnostic laboratory, who stated the body was submitted and the necropsy results are pending.