Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6310

2. Registrant Information.

Registrant Reference Number: 2013CK081

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

21-OCT-13

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. 11556-143

Product Name: K9 Advantix II Large dog

• 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.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

Due to the sensitive nature of the communication, specific relevant details were not obtained nor will they be sought. On an unspecified date in 2011, a 16 year old, male, Mixed Breed canine, in unknown condition, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) once 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

Cross breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

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

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

An unspecified time following the application of product the dog died due to unknown causes. No necropsy was performed. No more information is expected and the case is closed. Note: Previous application well tolerated. The caller contacted Bayer Animal Health to inquire about using the remainder of the product on their new pet and not to report this event.

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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

Death is not expected in dogs after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (medical history and time to onset unknown - necropsy not available) as the intent of the phone call to Bayer two years after the event was to inquire about using the remainder of the product on a new pet, and not to report the death of the patient. Other etiologies are more probable in this geriatric dog (16 years). It is known, that the dog had tolerated previous product applications well. Considering all aspects, a product connection is deemed to be unlikely.