Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6753

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0069899 (Report 536560)

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.

26-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

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. Unknown

Product Name: Advantage II pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXIFEN
    • 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 an unspecified date in 2012, a male, Poodle (Standard) canine, in unknown condition, with no known concomitant medical conditions, 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

Cat / Chat

3. Breed

Standard Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.5

7. Weight (provide a range if necessary )

Unknown

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

• Skin
  • Symptom - Burns (superficial)

• General
  • Symptom - Neoplasia

12. How long did the symptoms last?

Persisted until death

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 an unspecified date post application, in 2012, the dog exhibited an application site burn. On 03Jan2018, the dog was examined by a veterinarian, diagnosed with cancer and died. It is unknown if a necropsy was preformed. The owner was not calling to report the death of this patient but to inquire about use on another animal. No further information is expected. This case is closed. Follow up received on 26th Nov 2018: On 03Jan2013, the dog was examined by a veterinarian, diagnosed with cancer and died. It is unknown if a necropsy was preformed. The owner was not calling to report the death of this patient but to inquire about use on another animal. 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 In individual cases, dermal reactions at the application site are possible in animals that are particular sensitive. Would not expect application site burn directly related to the product however, likely dog scratched/ licked at site and caused skin lesions by self-trauma. Diagnosed cancer and death are inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Outcome was likely a consequence of cancer. The product has no carcinogen potential. Considering unknown time to onset, a product involvement is unassessable.