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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0939

2. Registrant Information.

Registrant Reference Number: 090142072

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-DEC-09

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

17-DEC-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 Over 60 lbs

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.987

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 December 17, 2009 the owner applied the product to the dog.

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

Dog / Chien

3. Breed

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

75

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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 December 23, 2009 the APSS technician recommended the owner take the dog to an emergency clinic right away and have the veterinarian call for information using the delayed case and follow up number provided.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On December 24, 2009 an APSS veterinarian contacted the owner to follow up the case. The owner stated the dog died on the way to the hospital on December 23, 2009, and they turned around and came home. The APSS veterinarian recommended a necropsy, to call the manufacturer directly with questions for the company, and call APSS back with questions. The owner stated the body was no longer available for necropsy. According to the veterinary toxicologist at APSS, the product was considered to have doubtful likelihood of causing the clinical signs.