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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3851

2. Registrant Information.

Registrant Reference Number: 110044255

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-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

14-APR-11

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 Medium Size Dogs 31 To 60

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

American Pit Bull Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Rectal hemorrhage
  • Skin
    • Symptom - Other
    • Specify - Warm Skin
  • 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?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On April 14, 2011 the product was applied to another dog in the home. The treated dog and this dog share a playpen. The owner noticed the dog was symptomatic. The owner contacted the Animal Product Safety Service (APSS) shortly after to obtain help. While on the phone, the owner noticed the dog had a rectal hemorrhage. The APSS veterinarian stated that dermal reactions are possible with the use of the product. The APSS assistant recommended taking the dog to the veterinarian.


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 that the substance was not considered to be related to causing the clinical situation. On April 19, 2011 an APSS assistant contacted the owner to update the case. The owner stated that the dog had died on the morning of April 15, 2011. The owner was planning to take the dog to the veterinarian that morning, but the dog died before she could do so.