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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5025

2. Registrant Information.

Registrant Reference Number: 090109606

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.

29-SEP-09

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

29-SEP-09

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. 2724-497-270

Product Name: Bio Spot Spot On Flea and Tick Control for Dogs Medium Size

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Adducted
    • Symptom - Bizarre behaviour
    • Specify - Erratic behavior
    • Symptom - Seizure
  • General
    • Symptom - Hyperthermia
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On September 29, 2009 the owner found the cat had chewed on a tube of product and ingested some of the liquid. The APSS technician recommended that the owner call back after the kitten has been seen by the regular veterinarian.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On October 1, 2009 an APSS veterinarian called the owner to follow up the case. The owner reported that the regular veterinarian had given fluid therapy and attempted to manage the seizures but was unable to get the seizures under control overnight. He also stated that the kitten had passed away the following morning, September 29, 2009. The APSS veterinarian stated that cats are sensitive to concentrated permethrin products that can be found in some dog spot on products. This product was not used according to label directions: Do not use on cats.