Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-1429

2. Registrant Information.

Registrant Reference Number: 35603

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.

23-MAR-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-MAR-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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II pipette size unknown

• 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.

Unknown

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 21-Mar-2021, a 4 year old, 9 pound, neutered, male, Shih Tzu/Poodle (Miniature) crossbred dog, in unknown condition, with a concomitant medical condition of unspecified allergies, that was administered an unknown dose of oclacitinib maleate orally by the animal owner, and then was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu/Poodle (Miniature) crossbred dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

4.09

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Hair loss

• General
  • Symptom - Vocalizing

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 approximately 23-Mar-2021, the dog exhibited lethargy, alopecia, and vocalization. The dog was evaluated by a veterinarian, no treatments were performed, and the clinical signs continued. 30-Mar-2021 pet owner reports that on 23-Mar-2021, in the evening, she bathed the dog 3 times with ivory baby shampoo and on 24-Mar-2021 the 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