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: 2008-5842

2. Registrant Information.

Registrant Reference Number: 080109326

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.

29-SEP-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-SEP-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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 September 29, 2008, the owner inappropriately applied the product to his cat. The cat was too young.

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

Cat / Chat

3. Breed

Domestic Longhair Cat

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.16

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

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

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle tremors
  • General
    • Symptom - Weakness

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

The owner gave his cat a bath with a mild hand soap. The APSS veterinarian stated that when used as directed, significant systemic signs would not be expected unless an individual was extremely sensitive or allergic to one or more of the product ingredients. Ataxia and tremors would typically not be expected and may be indicative of an early systemic reaction. The APSS veterinarian recommended that the owner provide nutritional support in the form of tuna, cat food, or milk; thermoregulate the cat by covering the cat with a towel out of the dryer; monitor his cat at home; take his pet to the veterinarian if signs persist; and call back with questions. The owner called back on September 30, 2008. His cat appeared to be getting worse. The APSS technician stated that the cat needed to go to an emergency clinic for care.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a high likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Extra label use: do not use on on dog/cat under the age of 12 weeks.