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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4443

2. Registrant Information.

Registrant Reference Number: 080085928

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.

04-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

29-JUL-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. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs Under 15 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.

.034

Units: oz (fl) / oz (liquide)

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 July 29, 2008, the owner applied the product to her dog as a form of treatment

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Head shaking
    • Symptom - Trembling
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Abasia
  • General
    • Symptom - Lethargy
    • 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?

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

The owner bathed the animal multiple times with a baby shampoo. On July 30, 2008, the owner took the animal to a veterinary clinic where the attending veterinarian started to treat the animal for an ear infection with an antibiotic and ear drops. On July 31, 2008, the owner took the animal back to the veterinarian. The attending veterinarian took radiographs, ran blood work, provided fluid therapy, prescribed Tramadol and carprofen, and discharged the animal. The radiographs and the blood work results came back within normal limits. On the same day, the owner started giving the animal water and nutritional support through a syringe. The animal died at home on August 5, 2008. Severe, long term signs are not expected with use of the product.


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 doubted that this substance was related to causing the clinical situation.The APSS support staff recommended the animal be necropsied. The owner declined a necropsy.