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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3396

2. Registrant Information.

Registrant Reference Number: 080068022

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-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

21-JUN-08

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. 2724-497-27

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

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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 June 18, 2008, the owner applied the product as a preventative measure.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Parson Russell Terrier Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.95

7. Weight (provide a range if necessary )

15

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Eye
    • Symptom - Pupil dilation
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Pale mucous membrane colour
    • Specify - Pale Mucous Membranes
  • General
    • Symptom - Hypothermia
  • Gastrointestinal System
    • Symptom - Bloody stool
  • General
    • Symptom - Death

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

The clinical signs did not begin until June 21, 3 days after application of the product. According to the owners, the dog passed away at the veterinary clinic, only hours after clinical signs began. The APSS veterinarian stated that severe systemic effects are not expected with use of this product. The APSS veterinarian recommended that a necropsy be performed, but the dog was not available.


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 it was doubtful that this substance would have caused the clinical situation. Inappropriate use. Dosage incorrect. Rodentacide was noted as a possible cause.