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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1721

2. Registrant Information.

Registrant Reference Number: 2016CK001

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

Address: 2920 matheson BLVD

City: Mississaugua

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.

06-JAN-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-DEC-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. 27583      PMRA Submission No.       EPA Registration No.

Product Name: advantage II medium dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

A 10year female intact shih Tzu of unknown age was treated with 1 tube of advantage II medium dog on December 17th. The owner reported that the dog had not been eating prior to December 17th but regular went through phases of not eating.

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

shih tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

Unknown

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Eye
    • Symptom - Discharge eye
  • Respiratory System
    • Symptom - Laboured breathing
  • Eye
    • Symptom - Blindness (permanent)

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

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

2 days after product application, the dog became lethargic. On December 25th, the dog was recumbent, possibly blind, had eye discharge. The owner declined to bring the dog to a veterinarian for financial reasons. The dog was bathed in dish soap. 24hrs later the dog was less lethargic and started eating. On December 31st, the dog deteriorated and had labored breathing. The dog died on the way to an emergency clinic on January 1st. The owner declined necropsy for personal reasons. The veterinarian who did not examine the dog did not suspect Advantage for the clinical signs and subsequent death of the dog. The veterinarian suspected possible pyometra.


To be determined by Registrant

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

Death

19. Provide supplemental information here