Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-5272

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0037261 (Report 720040)

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-AUG-21

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

Unknown

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. 11556-152

Product Name: Advantage II Large Cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: SPINOSAD

• Active Ingredient(s)
  • SPINOSAD

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7. b) Type of formulation.

Other (specify)

spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 unspecified date in 2019, a 35 pound, intact, male, Maine Coon Cat feline of unknown age, in unknown condition, with no known concomitant medical conditions, was administered an unspecified dose of Comfortis (Spinosad) orally by the owner. On an unspecified date in 2020 the cat had 1 Advantage II Large Cat (Imidacloprid-Pyriproxyfen) applied topically by the owner.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

15.8757

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

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 an unspecified date in 2020 post application of Advantage II Large Cat the cat died. It is unknown if a necropsy was preformed.

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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; Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction which would have occurred in close proximity to product application. Other causes must be considered in animal with unknown health status and age. Previous exposure was well tolerated by animal. Additionally, the intent of the call was to inquire about product use in general and not to report this event. Considering the known product profile and unknown time to onset, and even no necropsy has been performed, sufficient information exists to conclude that the product did not cause the event. Overall, a product involvement was unassessable.