Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6024

2. Registrant Information.

Registrant Reference Number: 2010CP047US

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.

18-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

27-JUL-10

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. 25131      PMRA Submission No.       EPA Registration No.

Product Name: advantage 100

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

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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).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

boxer

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Difficulty Breathing

• Nervous and Muscular Systems
  • Symptom - Difficulty walking

• General
  • Symptom - Edema
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Owner called to report that she applied Advantage100 to her dog 26July10. on 27July10, owner noticed that her dog was having trouble breathing, can't really walk, and has swollen lips. The dog has had a stage 4 heart murmur for the past 3 years. Dog died in evening of July 27 2010

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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 signs, in particular death are not anticipated with appropriate product administration as inconsistent with the product`s pharmaco-toxicological profile. Signs and onset time are not consistent with an allergic (anaphylactic) reaction to the product either.