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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2408

2. Registrant Information.

Registrant Reference Number: 100032295

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.

17-MAR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

02-MAR-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.       PMRA Submission No.       EPA Registration No. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control for Cats 5 lbs and Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.804

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 March 1, 2010 the owner applied the product to 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 Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Dermatitis
    • Symptom - Itchy skin
    • Symptom - Hair loss
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Weight loss
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Depression
  • General
    • 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?

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 March 2, 2010 the owner bathed the cat. On March 4, 2010 the owner noticed the cat was slightly anorexic. On March 10, 2010 the cat became very anorexic and more depressed. On March 17, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended taking the cat to the veterinarian for laboratory tests and radiographs, and have the veterinarian call for information.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On April 29, 2010 the owner called the APSS to follow up the case and inquire about alternative means of flea control for the other pets in the household. The owner stated the cat died on March 20, 2010. The owner took the cat to the veterinarian for a nasoesophageal tube and necropsy. The attending veterinarian reported to the owner that the cat's liver was the color of nutmeg and externally looked like a nutmeg. The persistent signs and death are not related to the product aqpplication.