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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3103

2. Registrant Information.

Registrant Reference Number: 160024735

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-FEB-16

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

17-FEB-16

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 80 Lbs and Over

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-815

Product Name: Kirkland Signature Flea And Tick Control For Dogs 32-79 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.

Unknown

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 February 13th, 2016 the owner applied the over 80 lbs product as prevention. The owner stated the dog may have been licking the 32-79 product off of the other dog in the household.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Great Dane

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

150.0

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

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
    • Symptom - Retching
    • Symptom - Drooling
  • General
    • Symptom - Weakness
  • Blood
    • Symptom - Hyperglycemia
  • General
    • Symptom - Death

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 February 17, 2016 the dog developed anorexia. On February 20, 2016 the dog started vomiting, retching, developed hypersalivation, and weakness. On February 21, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated with the 32-79 lb product if ingested from other dog, might see short term mild GI upset. The APSS technician recommended taking the dog to the veterinarian, having the veterinarian call for information, and 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 APSS veterinarian stated that the over 80 lbs substance was not considered to be related to causing the clinical situation. The APSS veterinarian stated that the 32-79 lb substance was not considered to be related to causing the clinical situation. A follow up was not performed, because additional information was not expected (signs not related to use of product, and owner seemed to have no interest in following any recommendations). On February 21, 2016 the owner called the APSS back and stated she did take the dog to the veterinarian and the APSS assistant again recommended having the veterinarian call for information. On February 24, 2016 the owner called the APSS back and stated while at the veterinary clinic he was diagnosed with hyperglycemia, with a serum glucose of 700.0 milligrams per deciliter (mg/dL) and the dog died the evening of February 21, 2016. A necropsy was not available.