Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2010-0930

2. Registrant Information.

Registrant Reference Number: 090127982

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.

16-NOV-09

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

07-NOV-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 Spot On Plus Flea and Tick Control for Cats 5 lbs and Over

  • 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.

1.8

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 November 7, 2009 the owner inappropriately applied the product to a geriatric 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

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

7.8

lbs

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

  • General
    • Symptom - Vocalizing
    • Symptom - Lethargy
    • Symptom - Hiding
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Kicking
  • General
    • Symptom - Death
  • Renal System
    • Symptom - Other
    • Specify - inflammation of kidney
    • Symptom - Other
    • Specify - focal atrophy
    • Symptom - Other
    • Specify - fibrosis
  • Liver
    • Symptom - Other
    • Specify - cholestasis

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

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 November 8, 2009 the owners returned home and found the cat dead on the floor. The APSS veterinarian stated the cat's signs were not consistent with this exposure. The APSS veterinarian recommended the owner take the cat's body to the veterinarian and have the veterinarian call for information in regards to a necropsy and permethrin hair testing.


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 November 18, 2009 the regular veterinarian called the APSS to discuss the case. On November 30, 2009 necropsy results were received. Necropsy results reveal that the cause of death remains undetermined. There were signs of inflammation within the kidney and signs of disease within the liver which may be associated with the demise of the cat. The report also noted that due to marked autolysis of tissues, subtle toxic changes may have been obscured. Later that day, the APSS veterinarian called the owner to update her on the cat's necropsy results. Hair testing results are pending.