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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6481

2. Registrant Information.

Registrant Reference Number: 130116985

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.

21-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

15-AUG-13

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. 2724-814

Product Name: Kirkland Signature Flea And Tick Control For Cats 5lbs 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 August 14, 2013 the owner applied the product to the cat to prevent fleas.

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 )

8.0

7. Weight (provide a range if necessary )

9.59

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Hiding
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Seizure
  • 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?

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 August 15, 2013 the owner noticed that the cat was hiding. On the morning of August 16, 2013 the owner noticed that the cat was vocalizing, anorexic, and lying in the corner (which was a change in her normal behavior). Later that day the owner took the cat to the veterinarian, where fluid therapy, Dexamethasone, and Marbofloxacin were given. The cat became agitated later that day at the clinic, so the cat was given Diazepam. Later that day the cat had an isolated seizure and died a short time later. A necropsy was done at the clinic, and grossly things seemed normal; histopathology results are pending. On August 21, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Etofenprox is classified as both a pyrethroid-like insecticide and a non-ester pyrethroid; it is safe to use on cats and dogs, and does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian also stated that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste. The APSS veterinarian said that some animals will hypersalivate just from the odor of the product. The APSS veterinarian stated that seizures and death would not be expected.


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 considered to be related to causing the clinical situation.