Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-0920

2. Registrant Information.

Registrant Reference Number: 32315

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.

19-FEB-20

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

13-FEB-20

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)

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PMRA Registration No. 27582      PMRA Submission No.       EPA Registration No.

Product Name: advantage II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 13-Feb-2020, at approximately 2 pm, the mother of a 0.08 year old, 2.27 kg, male in good condition with no concomitant medical conditions was administered one ADVANTAGE II 4 X 2.5 ML LGE DOG, (-), by Animal owner. The product was used according to label (Yes).

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.08

7. Weight (provide a range if necessary )

2.27

kg

8. Route(s) of exposure

Unknown

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

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

The puppy may or may not have come into contact with the Advantage II that was applied to his mother. At approximately 8 pm that evening, the puppy became lethargic and inappetant. At approximately 2 am, the puppy passed away. The puppy's remains have been sent for necropsy. All other puppies in the litter are healthy.

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To be determined by Registrant

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

Death

19. Provide supplemental information here