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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1455

2. Registrant Information.

Registrant Reference Number: 100159798

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.

10-DEC-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

08-DEC-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. 19211      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Collar for Dogs with Integral Buckle

  • Active Ingredient(s)
    • PROPOXUR

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

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 December 7, 2010 the pet owner placed the collar on the dog.

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

Maltese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

1.5

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Drooling
  • Nervous and Muscular Systems
    • 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.

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On December 8, 2010 the pet owner noticed that the dog had severe diarrhea. The pet owner bathed the dog with a flea shampoo on December 9, 2010. Also on this date the pet owner noticed that the diarrhea had improved. However, further symptoms developed and shortly after those signs began, the dog died. The pet owner contacted the Animal Product Safety Service (APSS) on December 13, 2010. The dog's body had already been submitted for necropsy. The APSS veterinarian stated that with oral exposure to the product, vomiting, diarrhea, and salviation may be seen but serious nicotinic signs are unlikely with routine use.


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 seizure activity and death would not be expected. The necropsy results revealed a decreased cholinesterase level.