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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4626

2. Registrant Information.

Registrant Reference Number: 1151947

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 295 Henderson Drive

City: Regina

Prov / State: SK

Country: Canada

Postal Code: S4N 6C2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

18-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

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. 72155-82

Product Name: BAYER ADVANCED 12-MONTH TREE & SHRUB PROTECT AND FEED CONCENTRATE II

  • Active Ingredient(s)
    • CLOTHIANIDIN
      • Guarantee/concentration .37 %
    • IMIDACLOPRID
      • Guarantee/concentration .74 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

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

Doberman Pinscher

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

84.20

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Liver
    • Symptom - Other
    • Specify - Elevated liver values

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

4/18/2013 Caller has a dog that she recently adopted, and she brought the dog to the veterinarian for its initial evaluation and it was discovered that the dog had elevated liver values. The caller was unable to describe what specific tests of liver function were abnormal. Caller speculates that the dog may have been exposed to the product, but no direct exposure was witnessed. 4/22/2013 Callback attempted to the original caller. A message was left requesting follow up information. 4/26/2013 Callback attempted to the original caller. A message was left requesting follow up information. Owner eventually followed-up on 4/26/2013 and reports that the dog died on 4/21/13. Owner states that this dog was 20 pounds underweight and severely malnourished upon adoption. The veterinarian ruled out any involvement of the product.


To be determined by Registrant

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

Death

19. Provide supplemental information here