Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6295

2. Registrant Information.

Registrant Reference Number: 2013CK066

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 Advantix II Unspecified

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

---

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 Sep-2012, a 5 month old, intact, male, Mastiff canine, of unknown weight, in good condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (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

Mastiff

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.42

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

• Reproductive System
  • Symptom - Birth defect
  • Specify - congenital malformation of the cervical vertebra

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 an unknown date post application, the dog was diagnosed with a congenital malformation of the cervical vertebra, cervical spondomyelopathy. On an unknown date in Mar-2013, the dog died. No necropsy was performed.

---

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 after product application, as inconsistent with pharmaco-toxicological product profile. Time to onset is precisely known, however, seems several month. The dog was diagnosed with a congenital malformation of the cervical vertebra, cervical spondomyelopathy. Death may be related to the reported medical status. Although no necropsy performed, product involvement rather unlikely as onset time very long