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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1462

2. Registrant Information.

Registrant Reference Number: 110013415

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.

01-FEB-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

30-JUL-10

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 Large Size Dogs Over 60 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.

2.987

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 1, 2010, the owner applied the product to her dog and continued monthly until September 1, 2010.

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

Chesapeake Bay Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

78.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • General
    • Symptom - Jaundice
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Pica
    • Symptom - Pale mucous membrane colour
  • Blood
    • Symptom - Anemia
    • Specify - Immune Mediated Hemolytic Anemia
  • 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

On July 30, 2010, the owner noticed the dog had icterus. Later, on August 15, 2010, the owner noticed the dog was vomiting and had pica. On October 25, 2010, the owner noticed the dog had a pale mucous membrane color. Later on October 25, 2010, the owner took her dog to the veterinarian, where it was diagnosed with immune mediated hemolytic anemia. On October 20, 2010, the dog died. On February 1, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that dermal reactions can occur with the use of the product. The APSS veterinarian also discussed flea treatment with the owner.


To be determined by Registrant

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

Death

19. Provide supplemental information here

A necropsy was rejected as the body was unavailable. According to the veterinary specialists at APSS the product was not related to the clinical signs.