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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0926

2. Registrant Information.

Registrant Reference Number: 090122779

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.

02-NOV-09

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

18-OCT-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. 2724-488

Product Name: Zodiac Spot On Flea Control for Cats and Kittens

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

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 October 16, 2009 the owner applied the product to the 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

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 )

7

7. Weight (provide a range if necessary )

8.3

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Depression
  • General
    • Symptom - Hyperthermia
  • Respiratory System
    • Symptom - Panting
  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Death
    • Symptom - Fever
  • Gastrointestinal System
    • Symptom - Weight loss

12. How long did the symptoms last?

Persisted until death

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 October 18, 2009 the owner noticed the cat was a little depressed and may have had a fever. The signs seemed to be resolving, but on October 22, 2009 the owner found the cat dead. On October 23, 2009 the owner took the cat into the regular veterinarian for a physical exam and returned the unused product to the place of purchase. The APSS veterinarian stated methoprene is an insect growth regulator and with dermal exposure via use of spot on products, signs are not expected. She also stated that oral exposure from grooming may result in a taste reaction, but more significant signs are not expected. She stated that this cat's illness and demise are not likely related to product use due to the timing of onset of illness and death several days later. The APSS veterinarian recommended a necropsy, which was not available as the body was cremated shortly after death, and to obtain addition information from the regular veterinarian.


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 3, 2009 an APSS veterinarian called the veterinary clinic to follow up the case. The regular veterinarian stated that the cat was examined on November 1, 2008 for pruritus and that the cat had experienced weight loss between that date and the time of death. He also stated that there were no apparent external lesions, and a postmortem exam was not done.