Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6022

2. Registrant Information.

Registrant Reference Number: 2010CP045US

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. 25132      PMRA Submission No.       EPA Registration No.

Product Name: ADVANTAGE 20 FLEA ADULTICIDE FOR DOGS 8 WEEKS AND OLDER WEIGHING BETW

• 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.

1

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

boston terrier

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia
  • Symptom - Retching

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Death
  • Symptom - Adipsia

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

A few hours after application the dog started to vomit. This morning the dog is no longer vomiting, however it is dry shaking, and not eating or drinking. No treatments have been done and the dog has not been seen by the dvm. The dog has had the product for about one year without side effects. Dog died 4 days later; it was not seen by a veterinarian and no post mortem was done. The owner did say that the dog prior to the advantage being applied was slowing down and acting lethargic.

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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 are not typically seen with appropriate topical product administration. No oral exposure to product observed or suspected. Signs are not uncommon in dogs and may have multiple potential other causes. According to the owner, the dog was ill and lethargic prior to product administration. So, other underlying problems were likely in this dog. Death is not anticipated with product use and likely was associated with an underlying illness.