Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0773

2. Registrant Information.

Registrant Reference Number: 2010CP093US

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.

11-JAN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

28-JUN-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. 25128      PMRA Submission No.       EPA Registration No.

Product Name: advantage 9

• 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

Cat / Chat

3. Breed

persian

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

15

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

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

11. List all symptoms

System

• General
  • Symptom - Polydipsia
  • Specify - drinking a lot of water
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

Caller applied product to cat on 6/27/10. The next day cat began drinking a lot of water. Cat is eating normally but has lost a lot of weight and seems lethargic. Patient name:Amber. : Owner reports that Amber passed away at home approximately 2 weeks after contacting.

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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

Signs are not anticipated with appropriate product administration as non-consistent with the product`s pharmacological profile. Weight loss and polydipsia are suggestive of other underlying medical conditions in this geriatric cat. Death is not anticipated with appropriate topical product use. Time between product application and death is about 2.5 weeks which is a too long timeframe for a product connection. Without medical exam and necropsy, cause for signs and death unclear.