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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6452

2. Registrant Information.

Registrant Reference Number: 130097075

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.

15-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

15-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 Dogs 13 to 31 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.

3

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 14, 2013 the owner applied the product to the dog to prevent fleas; the owner suspects that the dog was able to lick some of the product.

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

Canine Domestic Unspecified Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Eye
    • Symptom - Other
    • Specify - Eyes Rolling Back
  • Nervous and Muscular Systems
    • Symptom - Stiffness
  • General
    • Symptom - Other
    • Specify - Difficulty Closing the Mouth
    • Symptom - Vocalizing
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Gastrointestinal System
    • Symptom - Dry mouth
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Drooling

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

On July 15, 2013 the owner noticed that the dog was vocalizing, putting her snout up in the air, and experiencing hyposalivation. A short time later that morning the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that spot on products such as this one could cause local hypersensitivity and that sometimes paresthesia-type reactions are also seen when pyrethroids are involved. The APSS veterinarian also stated that the signs the owner described seemed more like seizures and would not be consistent with use of the product. The APSS veterinarian recommended that the owner bathe the dog with a liquid dish washing detergent (LDWD), give the dog some milk, and call 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

Later on the morning of July 15, 2013 the owner contacted the APSS to update the case. The owner stated that in addition to the signs mentioned previously, since earlier that morning the dog's eyes were rolling back, she was stiff, and she had difficulty closing her mouth. The owner stated that she bathed the dog with LDWD and gave the pet some water instead of milk, as her milk had expired. The APSS assistant recommended that the owner take the dog to the veterinarian and have the veterinarian call for information. On July 22, 2103 the company contacted the APSS to update the case. The call center staff stated that the dog had died at an unknown time. A necropsy was not available.