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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8700

2. Registrant Information.

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.

14-AUG-07

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

Unknown

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)

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

Product Name: advantage 55

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

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

Dog / Chien

3. Breed

terrier cross

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

25

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 yr / > 1 an

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Confusion
    • Specify - senility

12. How long did the symptoms last?

<=30 min / <=30 min

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

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

The owner reports the dog would develop gran mal seizures within 24 hours following the application of the product. The dog's symptoms would not appear when the dog was not given the product. The owner said the dog eventually went senile. The dog died peacefully at home.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The product's wide margin safety and topical mode of action was discussed. Unknown causality. The dog was elderly and most likely the onset of symptoms is coincidental to the application