Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6304

2. Registrant Information.

Registrant Reference Number: 2013CK075

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.

15-JUL-12

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. 11556-144

Product Name: K9 Advantix II Extra 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.

4

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 approximately 01Jul2012, a 10 year old, female, Australian Shepherd of unknown weight, in good condition, with no known medical conditions, was administered 1 tube of K9 Advantix II Extra 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

Australian shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

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

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

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 15Jul2102, the dog passed away. A necropsy was performed and did not reveal any abnormalities. No more information is expected. Case is closed. Note: The dog had tolerated previous application well. The attending veterinarian deemed the dog to have died from the natural cause of old age. The intent of the phone call to Bayer was to inquire about the expiration date of the product and not to report the death of the patient.

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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. Other causes are more probable. In this case necropsy did not reveal any abnormalities and the attending veterinarian deemed the dog to have died from the natural cause of old age (10 years old). Besides, inconsistent time to onset (14 days) and the dog had tolerated previous product applications well. The intent of the phone call to Bayer one year after the dogs death was to inquire about the expiration date of the product and not to report the death of the patient. Considering all aspects, a product connection is deemed to be unlikely.