Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0241

2. Registrant Information.

Registrant Reference Number: 120142443

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.

11-OCT-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-OCT-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)

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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 October 10, 2012 the owner sprayed the cat 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

Medical Professional

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 )

10.0

7. Weight (provide a range if necessary )

2.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Hypothermia
  • Symptom - Other
  • Specify - hyperthyroidism

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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 October 11, 2012 the owner noticed that the cat was having tremors. Later that morning, the owner took the cat to the veterinarian, where the cat was bathed with liquid dish washing detergent (LDWD), given fluid therapy subcutaneously, 0.1 milligram (mg) of acepromazine subcutaneously, and 250 mg of methocarbamol rectally followed by 500 mg of methcarbamol after the bath. At the clinic, that cat was observed to be hypothermic, with an initial temperature recorded as 35.9 degrees Celsius. The owner's regular veterinarian then provided thermoregulation and gave the cat 2 mg of diazepam. A short time later, the cat's temperature was recorded as 35.1 degrees Celsius, which was still low. A short time later that morning, the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the pyrethrin content in the product is low and may cause mild fasciculations in sensitive individuals. The APSS veterinarian also stated that the cat's signs were more consistent with an exposure to permethrin. The APSS veterinarian recommended that the owner's regular veterinarian control the cat's existing signs with propofol, diazepam, and gas anesthesia as needed; continue giving methocarbamol by mouth for 2 to 3 days at 66 to 132 mg/kilogram (kg)/day divided; provide symptomatic and supportive care; and call 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 October 15, 2012 an APSS assistant called the owner's regular veterinarian to update the case. The owner's regular veterinarian stated that at an unknown time the cat was given methocarbamol; she also stated that by the afternoon of October 11, 2012 the cat was no longer hypothermic. The owner's regular veterinarian said that a diagnostic evaluation was performed later on October 11, 2012 which revealed that the cat had hyperthyroidism, which was a pre-existing condition that had just been discovered. The owner's regular veterinarian also stated that on October 12, 2012 the cat's tremors were milder and the cat was sent home with methocarbamol. Later on October 15, 2012 the owner called to update the case. The owner said that the cat had fully recovered earlier that day and she wanted to discuss reimbursement for medical costs. The APSS assistant referred the owner to the product's manufacturer.