Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2879

2. Registrant Information.

Registrant Reference Number: 2010CP021

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.

02-APR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-MAR-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.       PMRA Submission No.       EPA Registration No. 25128

Product Name: advantage9

• 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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?

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

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

• Gastrointestinal System
  • Symptom - Salivating excessively

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Pulmonary edema
  • Specify - lungs fluid-filled

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

DVM reports product had been used on cat in the past without incident, but cat died within 12 hours of applcation of product on 16 Mar 2010. Cat presented to clinic with fleas and mild anemia on 16 Mar 2010; product was applied by technician at that time. Later that day, cat hypersalivated while in litter box, then fell over on her side, began gasping for air, and was promptly brought back to clinic. DVM reports cat was deceased upon presentation at clinic. Cat has a history of renal failure but no history of drug reactions. DVM reports cat's lungs were fluid-filled upon presentation. DVM does not suspect product involvement in development of signs.

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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

Although salivation may be suggestive of product ingestion, pulmonary emphysema not expected. Reported signs, except salivation, and sudden death not anticipated following product application as inconsistent with pharmactoxicological product profile. Cat tolerated product in past without incident. Cat had history of anemia and renal failure.