Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2010-2152

2. Registrant Information.

Registrant Reference Number: 0100010560

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-JAN-10

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

6. Date incident was first observed.

30-JAN-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.       PMRA Submission No.       EPA Registration No. 2724-504

Product Name: Zodiac Spot On Plus F and T Control for Cats and Kittens Under 5 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

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 January 30, 2010 the owner applied the wrong sized dose of the product to 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

Animal's Owner

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 )

0.71

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

12. How long did the symptoms last?

Persisted until death

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

Died

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 January 30, 2010 the owner rinsed the cat with water and then took her into the veterinarian. The veterinarian managed tremors and seizures with methocarbamol, diazepam, and propofol. The cat also received fluid therapy. The APSS veterinarian recommended the owner have the veterinarian call for information and contact the manufacturer for her reimbursement question.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On January 31, 2010 the emergency veterinarian called the APSS to update the case. The APSS veterinarian recommended hair testing. On February 1, 2010 an APSS assistant called the emergency clinic to follow up on the hair testing. The emergency veterinarian said the cat died on January 31, 2010, and they were planning on doing the hair testing. The APSS assistant recommended a necropsy, and referred the owner to the manufacturer again. On February 2, 2010 an APSS technician called the emergency clinic to follow up on the hair testing and necropsy. The emergency veterinarian stated that the hair samples were sent out on February, 1 2010, and the owner rejected the necropsy. The hair testing is pending. Product was not used according to label directions: wrong sized dose used.