Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3166

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0026175 (Report 567638)

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.

29-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

30-NOV-18

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9advantixII 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.

Other (specify)

spot on

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 28-Nov-2018, a 14 year old, female Schnauzer - Miniature dog, of unknown weight, in unknown condition, with the concomitant medical condition of heart disease, was administered an unspecified heartworm preventative orally 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

Unknown

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 - Death

• Gastrointestinal System
  • Symptom - Other
  • Specify - Pancreatitis

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On approximately 30-Nov-2018 the dog was examined by a veterinarian, was diagnosed with pancreatitis and died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought.

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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

O - Unclassifiable/unassessable Reported pancreatitis and death are not expected after product application, as they are inconsistent with the pharmaco-toxicological profile of the product. Other causes should be considered in this geriatric dog (e.g. concomitant medical condition of heart disease). Considering that the time to onset is more than 12 hours, an allergic/anaphylactic-type reaction can be ruled out. Overall, a product connection is unassessable.