Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1556

2. Registrant Information.

Registrant Reference Number: 2013AM047 - US0009781

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.

01-JUN-12

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-JUN-12

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.

Product Name: Advantage 10

• 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).

On approximately 01-Jun-2012, a 14 year old, 6 pound, spayed, female, Yorkshire Terrier canine, in fair condition, with no known concomitant medical conditions, was administered 1 tube of Advantage 10 Topical Solution once topically by the owner.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

6

lbs

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

• Unknown
  • Symptom - Other
  • Specify - Lethargy, halitosis, malodour

• General
  • Symptom - Lethargy

• Renal System
  • Symptom - Renal failure

• General
  • Symptom - Death
  • Symptom - Bad breath
  • Specify - halitosis
  • Symptom - Other
  • Specify - malodour

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

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

12 hours after application the patient had no energy (lethargy) and had a bad smell on her body and breath. On approximately 02-Jun-2012, the lethargy resolved. On approximately 04-Jun-2012, the bad smell resolved. On approximately 01-Jul-2012, the patient died from renal failure. The intent of the phone call to Bayer was to inquire about a new pet, and not to report the death of the patient or any adversity with this product.

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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