Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0081

2. Registrant Information.

Registrant Reference Number: 100053675

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.

30-APR-10

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

29-APR-10

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Under 14 kg

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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 April 29, 2010 the owner inappropriately applied the product onto the nursing 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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

8.4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Hyperthermia

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?

17

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 April 29, 2010 shortly after application, the owner took the cat to the veterinarian, where valium was administered. The attending veterinarian noted the cat had a temperature, so cold compresses were applied, and fluid therapy was started. On April 30, 2010 the attending veterinarian contacted the Animal Product Safety Service (APSS) to find out if it was safe to allow the two day old kittens to nurse. The APSS veterinarian recommended not allowing the kittens to nurse until the cat had been thoroughly bathed with liquid dish washing detergent.

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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 5, 2010 an APSS technician contacted the veterinarian clinic to update the case. The attending veterinarian stated that the cat was released from the hospital and had made a full recovery on April 30, 2010. This product was not used according to label directions: do not use on cats.