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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6499

2. Registrant Information.

Registrant Reference Number: 130112403

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.

12-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

Unknown

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 8, 2013 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 )

11.0

7. Weight (provide a range if necessary )

9.0

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Drooling
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Death
  • Liver
    • Symptom - Other
    • Specify - feline hepatic lipidosis.

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

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

Sometime after the exposure to the product on August 8, 2012 or on August 9, 2013 the owner noticed that the cat was symptomatic. On August 11, 2013 the owner bathed the cat. On the morning of August 12, 2013 the owner took the cat to the veterinarian. Later that day the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that contact hypersensitivity could occur, as with any topical exposure. The APSS veterinarian also stated that if the product was ingested, gastrointestinal (GI) upset and/or a taste reaction could occur. The APSS assistant recommended that the owner have his 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

On November 5, 2013 diagnostic laboratory staff contacted the APSS to update the case and provide a necropsy report. Per the diagnostic laboratory, the cat died suddenly on August 13, 2013 and was brought into the veterinary clinic that day; the cat's body was then shipped to the diagnostic laboratory for a necropsy. The necropsy results revealed that autolysis was prominent in the cat and precluded any meaningful interpretation of the many tissue changes; the gross necropsy and histopathology studies confirmed that at least mild hepatic lipidosis was present in the cat, and this might be significant if there were any clinical signs suggestive of feline hepatic lipidosis. As for the possible pyrethroid toxicity from the application of the flea product, it could be a possibility; cats, unlike other vertebrates, cannot metabolize and detoxify pyrethroid derivatives due to the absence of a Beta-Glucuronidase enzyme in the liver, and toxicity can occur. However, pyrethroid toxicity does not produce any gross or histologic changes. No other underlying disease problems were found in the cat aside from the incidental finding of a black colored trichobezoar of 5 centimeters (cm) x 3 cm x 3 cm dimension in the stomach.