Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6123

2. Registrant Information.

Registrant Reference Number: 2015KP240

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd. East

City: Mississauga

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.

19-OCT-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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 unknown dog

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

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7. b) Type of formulation.

Liquid

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 unknown date in Aug2011, the owner applied one tube of Advantage II unspecified (imidacloprid-pyriproxyfen) topically to a beagle of unknown sex, weight, age.

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

Beagle

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

• Blood
  • Symptom - Other
  • Specify - Septicaemia

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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 unknown date in Sep2011, the dog ingested a stick, became septic and died. No necropsy was performed. No more information is expected and the 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

Reported application site disorders and generalized skin disorders are not related with product as signs occurred before product application. Death and septicemia are not expected after product application, as inconsistent with pharmaco-toxicological product profile. No oral exposure of the product. In this case animal ingested stick, which may have further resulted into septicemia and death of the animal. Exact time to onset unknown. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (4 years). Though necropsy was not performed, sufficient information exists to rule out product involvement. Finally, a product relation considered as unlikely.