Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2950

2. Registrant Information.

Registrant Reference Number: 2009TH028

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

Address: 77 Belfied Road

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.

08-JUN-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUN-09

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. 25127      PMRA Submission No.       EPA Registration No.

Product Name: advantage 55

• Active Ingredient(s)
  • IMIDACLOPRID

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PMRA Registration No. 25131      PMRA Submission No.       EPA Registration No.

Product Name: advantage 100

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

6.5

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).

A tube of each advantage 55 and advantage 100 were used as the dog is 136 lbs. The 55 was not required. Interceptor white and yellow were also given on the same day.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Great Dane

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.3

7. Weight (provide a range if necessary )

136

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Bad breath
  • Specify - medicinal smell to breath
  • Symptom - Other
  • Specify - gurgling stomach noises
  • Symptom - Other
  • Specify - medicinal smell to stool

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

The owner treated with both products on the AM of June 1. In the PM the owner noticed the dog was lethargic and there was a medicinal odor to the dog's breath and stool. June 2 the owner noticed the dog had a gurgling stomach. By June 4 the owner felt the dog was normal.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

The length of exposure is listed as 1 - 6 months as the dog was not bathed; the advantage would not have been removed.