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: 2013-0122

2. Registrant Information.

Registrant Reference Number: 120100278

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.

20-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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 Fleatrol 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).

Between July 1 and July 5, 2012 and again between July 8 and July 12, 2012 the owner sprayed the cat with the product to treat for fleas.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Ragdoll

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom -
    • Specify - Excessive Grooming

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

Between July 1 and July 5, 2012 the owner noticed that the cat was vomiting. Between July 8 and July 12, 2012, just after the second exposure to the spray product, the owner noticed that the cat was anorexic and grooming excessively as well. On July 14, 2012 the owner took the cat to the veterinarian and the cat was given an antibiotic. It is unknown if any other treatments were given while the cat was at the clinic. On July 17, 2012 the owner observed that the cat had made a full recovery. On July 20, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some cats are sensitive to the odors of sprays or when they groom themselves and that they might have mild or intermittent hypersalivation and possibly nausea. The APSS veterinarian also stated that if the product is used per label, significant gastrointestinal (GI) signs should not be expected. The APSS assistant recommended that the owner monitor the cat at home, have her veterinarian call to discuss the case further, 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

Later on the morning of July 20, 2012 the owner called back to ask if it was necessary for her veterinarian to call the APSS because her veterinarian does not make outgoing calls regarding patients. The APSS technician stated that as long as the cat remained asymptomatic the clinic did not necessarily need to call back, but that if any additional information about treatments performed at the clinic was available, the owner could call back. The APSS technician affirmed that the other recommendations given earlier that morning still applied. A follow up was not performed, because any signs that developed were expected to be mild and self-limiting. On July 26, 2012 the owner called the APSS to request the company's phone number to discuss reimbursement for the cat's treatment; the owner also stated that her veterinarian would not contact the APSS. The APSS veterinarian provided the owner the phone number for the company.