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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0116

2. Registrant Information.

Registrant Reference Number: 120094310

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.

09-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-JUL-12

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. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea And Tick Spray For Cats And Kittens

  • 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 July 9, 2012 the cat was sprayed with the product to prevent 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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

8.0

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 - Drooling
  • Eye
    • Symptom - Pupil dilation
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Retching

12. How long did the symptoms last?

Unknown / Inconnu

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?

2

Hour(s) / Heure(s)

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

On July 9, 2012, just after the product was sprayed on the cat, the owner's friend noticed that the cat was drooling, mydriatic, and having fasciculations. Preparing to leave for the veterinarian, the owner's friend observed that the cat had a seizure. A short time later, the cat arrived at the veterinary clinic, where the cat was bathed and given an oral medication to increase urine output. A short time later, the cat had fully recovered and was discharged from the clinic. Later that afternoon, the owner's friend noticed that the cat was retching. Later that day, the owner's friend contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the main concern was for a taste reaction, gastrointestinal (GI) upset, and dermal hypersensitivity; seizures would not be expected. The APSS veterinarian also stated that the retching wouldn't be expected to be related to the use of the product unless there were still significant material on the cat's fur that she was licking off; the APSS veterinarian noted that seemed unlikely. The APSS veterinarian recommended that the owner monitor the cat at home, give food in a few hours, call back with questions, and have the veterinarian call for information if there were any questions. The APSS veterinarian also referred the owner to the manufacturer to discuss reimbursement.


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 doubtful likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.