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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5567

2. Registrant Information.

Registrant Reference Number: 100112325

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.

27-AUG-10

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

04-AUG-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)

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 June 30, 2010 and again on July 31, 2010 the owner applied the product onto the cat to treat an existing flea problem.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • Eye
    • Symptom - Glazed eye
  • Renal System
    • Symptom - Other
    • Specify - Oliguria
  • Gastrointestinal System
    • Symptom - Constipation
    • Specify - Absent Bowel Movements
  • General
    • Symptom - Hyperthermia
    • Symptom - Death

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 August 4, 2010 the cat became symptomatic. On August 7, 2010 the owner took the cat to the veterinarian, where the cat was hyperthermic, so the veterinarian started fluid therapy and symptomatic care by giving antibiotics. On August 15, 2010 the cat died. On August 27, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated S-Methoprene is an insect growth regulator with a wide margin of safety. The APSS veterinarian also stated systemic toxicity is not expected and the cat's signs are inconsistent with the reported exposure. The APSS veterinarian recommended a necropsy and to have the attending veterinarian call for information.


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. A follow up was not performed, because additional information was not expected. On September 1, 2010 the attending veterinarian called the APSS to update the case. The APSS veterinarian discussed the case with the attending veterinarian and the APSS veterinarian explained that since the cat had been buried for 5 days, necropsy would be unlikely to provide any information.