Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0089

2. Registrant Information.

Registrant Reference Number: 110059096

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.

15-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-MAY-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)

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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

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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 May 14, 2011 the owner applied most of the bottle of the product onto the cat.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Fasciculations
  • Symptom - Muscle tremors

• General
  • Symptom - Adipsia

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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?

1

Day(s) / Jour(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 May 15, 2011 the cat became symptomatic. Later that day the owner took the cat to the emergency clinic where they rinsed the coat and skin. Shortly after, the emergency veterinarian called the Animal Product Safety Service (APSS). The APSS veterinarian recommended fluid therapy, monitoring the cat's body temperature, providing thermoregulation, methocarbamol, diazepam, monitoring at the veterinary center, managing tremors and seizures, providing symptomatic and supportive care, and calling back with questions.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On May 21, 2011 an APSS assistant called the emergency clinic to update the case. The emergency veterinarian stated they had given fluid therapy, monitored the cat's body temperature and provided thermoregulation, gave methocarbamol, monitored the cat at the emergency clinic, provided symptomatic and supportive care. The emergency veterinarian also stated the cat was kept at the clinic for almost 24 hours, then sent home, and had fully recovered by May 16th. The cat was sprayed too heavily way beyond the recommended label amount.