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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0820

2. Registrant Information.

Registrant Reference Number: 140131512

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.

16-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

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 5 Lbs 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 June or August of 2012 the owner applied the product onto her cat as the first and only treatment.

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

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Weight loss
  • Renal System
    • Symptom - Other
    • Specify - Urinary Tract Infection
    • Symptom - Other
    • Specify - Pyelonephritis
  • 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?

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

The cat developed over a period of 2 years, symptoms and pyelonephritis. On October 7, 2014 the owner took the cat to the veterinarian. On October 8, 2014 the cat died. On October 16, 2014 the owner contacted the company to report the death and to relay to the company that she believes the product is what killed her cat. The owner stated that the symptoms were ongoing for the past 2 years and she had many different visits to the veterinarian where different treatments and antibiotics were given to try to help with the symptoms. The company assistant recommended the owner speak with the Animal Product Safety Service (APSS), but the owner declined. The company veterinarian stated topical use of synthetic pyrethroid-like flea preparations as per label directions is not expected to cause significant clinical signs. The company assistant recommended calling back with questions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The company veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was not available.