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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1779

2. Registrant Information.

Registrant Reference Number: 140001733

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.

06-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

22-JUL-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. 2724-815

Product Name: Kirkland Signature Flea And Tick Control For Large Dogs 32 to 79 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 30 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

6

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 July 7, 2013 and again on July 21, 2013 the owner applied the product to the dog to treat for 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

Dog / Chien

3. Breed

Smooth Collie

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 )

75.0

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Paralysis
    • Specify - Hind Limb Paralysis
  • Gastrointestinal System
    • Symptom - Anorexia
  • 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 July 22, 2013 the owner noticed that the dog had hind limb paralysis. A short time later that evening the owner took the dog to an emergency veterinary clinic, where the dog was monitored overnight and various unspecified testing was performed. The next morning, July 23, 2013, the dog was transferred to her regular veterinarian, where she was observed to have a severe flea infestation. On the morning of July 24, 2013 the owner's regular veterinarian referred the owner to a specialty clinic, where a tick profile was done. That morning the owner took the dog home, monitored the dog, and provided unspecified supportive care to the dog. On July 26, 2013 the owner noticed that the dog was anorexic and not improving, so she took her back to her regular veterinarian; the regular veterinarian gave the dog a Corticosteroid injection, which was not effective. The owner continued to monitor the dog and provide supportive care at home after returning from the regular veterinary clinic. On July 28, 2013 the owner observed that the dog died. On January 6, 2014 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 because it is structurally different. The APSS veterinarian said that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste. The APSS veterinarian stated that hind limb weakness and death are not expected. A necropsy was not available to determine the dog's cause of death.


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.