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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3383

2. Registrant Information.

Registrant Reference Number: 080046525

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.

03-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

03-MAY-08

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. 40849-72-2724

Product Name: Zodiac Fleatrol Spot On Flea Control For Large Dogs Over 30 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

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 May 3, 2008, the owner applied the product to his pregnant cat. Dog product used on 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

Medical Professional

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 )

1.5

7. Weight (provide a range if necessary )

7.8

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Skin
    • Symptom - Hyperesthesia
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Muscle tremors
  • Cardiovascular System
    • Symptom - Tachycardia
  • Respiratory System
    • Symptom - Tachypnea
  • Eye
    • Symptom - Nystagmus
  • General
    • Symptom - Hypothermia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Reproductive System
    • Symptom - Spontaneous abortion
  • General
    • 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?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

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 May 3, 2008, the APSS veterinarian stated that if the dog product was used, the signs coincide with a permethrin exposure. She recommended the emergency veterinarian monitor for central nervous system signs, manage tremors and seizures, provide symptomatic and supportive care, and call back with questions. The attending emergency veterinarian followed the APSS recommendations and managed the animal's tremors and seizures with robaxin, diazepam, and phenobarbital; gave her fluids and a bath; and administered atropine and isoflurane. On May 5th, the cat died.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Inappropriate use of product containing permethrin. The dog product was used on the cat, despite numerous warnings on the label.