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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3377

2. Registrant Information.

Registrant Reference Number: 080037793

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.

14-APR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

11-APR-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 16 to 30 lbs

  • 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.

,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).

Between April 6 and 11, 2008, the owner applied an incorrect dose of the product to the dog 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

14.6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Hyperthermia
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Hair loss
    • Symptom - Lesion
    • Specify - Papules
  • Gastrointestinal System
    • Symptom - Bloody diarrhea
  • General
    • Symptom - Parasitism
    • Specify - Parasitism
  • Blood
    • Symptom - Thrombocytopenia
    • Specify - Immune-mediated thrombocytopenia
  • 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?

Yes

14. b) How long was the animal hospitalized?

4

Day(s) / Jour(s)

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 APSS veterinarian recommended that the attending veterinary staff supply supportive and symptomatic care to the animal; give fluid therapy; perform a chemistry profile and a complete blood count; and give prednisone, gastrointestinal protectants, and antibiotics. The animal was diagnosed with alopecia, papules, parasites, bloody diarrhea, and immune-mediated thrombocytopenia. While at the veterinary clinic the animal was bathed, remained on fluid therapy, received a blood transfusion, and was monitored for central nervous system signs. Diagnostic blood work was performed; gastrointestinal protectants and prednisone were administered; and symptomatic and supportive cares were provided. Despite the veterinary clinic's efforts, the animal died on April 18, 2008.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product not used according to label directions. Incorrect dosage used. A necropsy was not performed because clinic determined the product was not the cause of death.