Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2057

2. Registrant Information.

Registrant Reference Number: 28870

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.

Human

Domestic Animal

4. Date registrant was first informed of the incident.

07-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-MAY-19

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II extra large dog

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

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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).

On 4-May-2019, a 2 year old, 38.9 kg, male neutered Golden Retriever in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 4.0 ML EX LGE DOG, KP0D1W3 KP0DO6J, KP0D1ZS KP0CVJV (-), 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 II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Tingling in mouth
  • Specify - lips

• Skin
  • Symptom - Tingling skin
  • Specify - fingers

4. How long did the symptoms last?

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

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 4-May-2019 Owner reported feeling tingling on her lips and fingers. On 5-May-2019 she was recovered

To be determined by Registrant

14. Severity classification.

15. Provide supplemental information here.

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 )

2

7. Weight (provide a range if necessary )

38.9

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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 4-May-2019 dog was lethargic, (dog had received vaccines on 3-may-2019)owner reported she herself felt tingling on her lips and fingers. On 5-May-2019 dog was fully recovered

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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