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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1682

2. Registrant Information.

Registrant Reference Number: 090010600

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.

28-JAN-09

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

27-JAN-09

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

Product Name: Zodiac SpotOn Plus FT Control For Cats and Kittens Under 5 Lbs

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

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 27, 2009, the owner applied the product to his cat.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair Cat

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.22

7. Weight (provide a range if necessary )

3.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Erratic Behavior
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Staggering
    • Symptom - Ataxia
    • Symptom - Seizure
  • General
    • Symptom - Death

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.

No

14. a) Was the animal hospitalized?

No

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 27, the owner wiped off the cat's skin and coat. On January 28, the owner took his pet to the veterinarian. The attending veterinarian called the Animal Product Safety Service (APSS) on January 28, 2009. Death or seizure activity would not be expected from the exposure. The APSS veterinarian recommended that the veterinarian have a necropsy performed. The attending veterinarian refused a necropsy.


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 low likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. The attending vet felt that the cat had pre-existing nervous system issues (presented to DVM with enlarged cranium). The product was unlikely the cause.