Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5078

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0046406 (Report 589120)

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.

08-AUG-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

02-AUG-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: advantageII pipette size unknown

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

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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 01-Aug-2019, an approximately 10 year old, approximately 40 pound, male, Retriever Labrador (No Description)/Poodle (Standard) crossbred canine, in unknown condition, with concomitant medical condition of fleas, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) topically by the 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

Crossbred [Retriever Labrador (No Description) x Poodle (Standard)]

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

18.144

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

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.

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 2-Aug-2019 the dog died at home. A necropsy was not performed. No further information is expected. This case is closed.

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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. The product was administered to puppies 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. Considering the product profile, product involvement is deemed rather unlikely, however due to limited information (necropsy was not performed) and short time to onset, case was considered to be unassessable.