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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0047

2. Registrant Information.

Registrant Reference Number: 110079678

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.

25-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

25-JUN-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. 19211      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Integral Buckle Flea and Tick Collar For Dogs

  • 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 June 25, 2011 the owner placed an inappropriately fitted flea and tick collar on the dog to treat for fleas.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

3.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

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

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 June 25, 2011, a few hours after placing the flea and tick collar on the dog, the owner returned home and saw that the dog had the collar stuck in its mouth and was trying to remove the collar. The owner immediately removed the flea and tick collar and wiped down the dog's coat and skin. Later that evening, the owner noticed the dog was symptomatic. Later that evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that a taste reaction and gastrointestinal (GI) upset could occur from the oral exposure to the flea and tick collar, and that trauma and stress could occur if the collar were stuck for a long period of time. The APSS assistant recommended that the owner give the dog a taste treat of some milk, monitor for GI signs such as vomiting, manage vomiting if it occurred by giving nothing by mouth for one hour and then slowly giving back water and then food, and call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Signs expected to be mild and self limiting. Label explains to: cut off any excessive length and discard it in the household garbage. Collars must be worn loosely, but securely enough to prevent easy removal. To release the collar, squeeze buckle between thumb and finger and pull sharply.