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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3388

2. Registrant Information.

Registrant Reference Number: 080054062

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.

22-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

12-MAY-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 Small Dogs 16 to 30 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 May 11, 2008, the owner applied the product to his dog as a preventative measure.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cocker Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

35

lbs

8. Route(s) of exposure

Skin

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

  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Disorientation
    • Symptom - Ataxia
  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Collapse
    • Symptom - Seizure
  • 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?

2.5

Hour(s) / Heure(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

On May 12, 2008, the owner contacted his local veterinarian and was advised to bathe the animal with liquid dish washing detergent. The attending veterinarian performed a physical exam and ran a chemistry profile and complete blood count. The attending veterinarian stabilized the animal with diazepam. The dog passed away later that day. The dog's history included a platelet abnormality. The APSS veterinarian recommended a necropsy be performed on the animal.


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 the clinical situation. The owner declined a necropsy. It is unclear if the proper dose was used on the animal since the weight of the animal is unclear.