Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3317

2. Registrant Information.

Registrant Reference Number: 36416

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.

28-JUN-21

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

24-MAY-21

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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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 an unknown date in May-2021, a 13 year old, 25.9 kg, Crossbred (Dog) in good condition with concomitant medical condition of untreated Cushings disease, was administered one K 9 ADVANTIX 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

Crossbred dog

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

25.9

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Lesion
  • Specify - Pustules
  • Symptom - Dermatitis

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 24-May-2021 the pet owner shaved her dog and noticed pustules along the spine. Pet owner cleaned the pustules with Chlorhexidine. On an unknown date at the beginning of Jun-2021 the pet owner applied an Advantage Multi 55 to the dog. On 11-Jun-2021 one of the pustuled areas began to ooze. On 24-Jun-2021 two of the areas on the spine had increased in size and were infected. 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