Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0381

2. Registrant Information.

Registrant Reference Number: 2014CK005

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.

16-JAN-14

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 (unknown size)

• Active Ingredient(s)
  • IMIDACLOPRID
    • Unknown

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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 unspecified date in 2000, an 18 pound, male, Shih Tzu canine of unknown age, in good condition with no concomitant medical conditions, was administered 1 tube of Advantage (dogunspecified) (Imidacloprid) 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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

18

lbs

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

• Eye
  • Symptom - Irritated eye

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Erlichiosis

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 unspecified date the canine was examined by a veterinarian for eye irritation. The canine was diagnosed with Erlichiosis. Approximately 1 week after the visit to the clinic the canine was hit by a car and died. No necropsy was performed.Note MAH: The information regarding the death of the dog was casually provided during an inquiry regarding her current pets and to discuss flea control.

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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

The information regarding the death of the dog was casually provided during an inquiry regarding her current pets and to discuss flea control. Reporting of occurrence 13 years after product application. Thus, reliability of data questionable. Nevertheless, eye irritation is not anticipated with topical product exposure. No direct ocular exposure was reported. Ehrlichiosis was diagnosed and also this sign is not anticipated and more likely related to an infection. Time to onset and chronology of signs unknown. However, the dog was killed on an unknown date after last product exposure due to a car accident. Cause for death unrelated to product use. In the end, product involvement was ruled out for signs and fatal outcome.