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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3853

2. Registrant Information.

Registrant Reference Number: 110051594

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-11

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

27-APR-11

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 Pounds 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.

1.2

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 27, 2011 the owner applied an inappropriate dose of the product to her 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 Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • General
    • Symptom - Adipsia
    • Symptom - Dehydration
    • Symptom - Hypothermia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death
  • Renal System
    • Symptom - Renal failure
    • Specify - kidney failure
    • Symptom - Other
    • Specify - lesions within the kidney

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 April 27, 2011 the owner noticed her cat was symptomatic. The drooling and vomiting ended later that evening. On April 30, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that severe signs as reported in this case are not expected when the product is used per label directions. The APSS veterinarian recommended taking the cat to the veterinarian, having the veterinarian call for information, bathing the cat, and providing vitamin E.


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 not related to causing the clinical situation. On April 30, 2011 the owner called back to update the case. She stated she took the cat to the veterinarian. The cat was dehydrated and hypothermic, with a temperature of 90.0 degrees Fahrenheit. The cat was bathed and provided with fluid therapy and thermoregulation. The owner stated that on May 1, 2011 the cat had a seizure and died a few hours later. The APSS veterinarian recommended a necropsy and the owner consented. Necropsy information was sent to the owner's veterinarian on May 2, 2011. The necropsy revealed significant lesions within the kidneys which suggest kidney failure was the cause of death.