Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5691

2. Registrant Information.

Registrant Reference Number: 34998

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.

13-NOV-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-NOV-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
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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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 12-Nov-2020, a 1.58 year old, 32 kg, male Golden Retriever in good condition with no concomitant medical conditions was administered one ADVANTAGE II 6 X 2.5 ML LGE DOG, (-), by Animal owner. The product was used according to label (No, dose is too low).

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.58

7. Weight (provide a range if necessary )

32

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Coughing
  • Symptom - Other
  • Specify - Unspecified Bronchial changes

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

Unknown/Inconnu

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 12-Nov-2020, 2 hours after application, the dog vomited a large amount of undigested food one time. On 12-Nov-2020 in the evening, an unknown time after application, the dog began coughing. On 13-Nov-2020 the dog was still coughing, was seen by a veterinarian who sedated the dog to perform radiographs. Mild bronchial changes were noted. The veterinarian does not feel the reaction was due to the Advantage II. The outcome is unknown.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here