Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-0533

2. Registrant Information.

Registrant Reference Number: 08-01-285990

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

12-DEC-08

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

11-DEC-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. 73049-300-2724

Product Name: Flea and Tick Sponge-On for Dogs and Cats

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 3 %
    • PYRETHRINS
      • Guarantee/concentration .3 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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).

4 oz. of product was mixed into a gallon of water and then splashed onto animal. The product was allowed to air dry and the owner did towel dry the pet a little.

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

Yorkie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.67

7. Weight (provide a range if necessary )

7.5

lbs

8. Route(s) of exposure

Skin

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

  • Nervous and Muscular Systems
    • Symptom - Semi comatose
    • Specify - in a trance
  • Gastrointestinal System
    • Symptom - Drooling
  • 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?

Unknown

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

Product was applied on December 9th. On December 11th, the owner noticed that when she fed the dog, she wasn't very excited like normal. The dog had her head pointed into the air just like she was in a trance. and going to fall over. It continued to happen on and off throughout the day. On December 12th, the dog was stuck in the trance and she wasn't excited to see the owner and was drooling. the dog was taken to the DVM the same day and placed on IV fluids. The dog died later that day. Caller refused to speak to Poison Control Professional.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Doubtfully related to product use. Timing of symptoms and clinical signs are not consistent with use of this product.