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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2863

2. Registrant Information.

Registrant Reference Number: 2015TH012

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd E

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

16-APR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

06-APR-15

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II extra large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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).

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

Leonberger

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

61

kg

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

  • Eye
    • Symptom - Red eye
  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Difficulty getting up
    • Specify - unable to stand
  • Gastrointestinal System
    • Symptom - Anorexia
  • Renal System
    • Symptom - Creatinine increased
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - BUN elevated
  • Renal System
    • Symptom - Anuria
  • General
    • Symptom - Pain

12. How long did the symptoms last?

Unknown / Inconnu

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?

2

Day(s) / Jour(s)

15. Outcome of the incident

Euthanised / Euthanasie

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 March 24 2015 a pet owner applied 1 tube of K9 advantix II XL to a 2 yr old 61 kg F Leonberger. On April 5 the dog was taken to a river to play. April 6 the pet owner noticed the dogs eyes were red. April 7 the dog was examined and treated for the red eye. April 9 the dog began to tremble and was unable to stand. April 10 the dog was not eating and seemed to be painful and was admitted to hospital. The pet was placed on IV fluids and bloodwork showed elevated BUN and CREA. The dog did not have any significant urine production. There was no evidence of anti-freeze toxicity and vector borne disease testing and lepto tests were negative. April 11 the pet owner s elected euthanasia


To be determined by Registrant

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

Death

19. Provide supplemental information here