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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0890

2. Registrant Information.

Registrant Reference Number: 1496374

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.

05-NOV-14

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

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. 432-763

Product Name: Suspend SC

  • Active Ingredient(s)
    • DELTAMETHRIN
      • Guarantee/concentration 4.75 %

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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

Boxer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

40.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Blood
    • Symptom - Leukocytosis
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Liver
    • Symptom - Elevated liver enzymes
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - BUN increase
  • Renal System
    • Symptom - Creatinine increased
    • Specify - creatinine increased
    • Symptom - Renal failure

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

11/5/2014 Caller is a veterinary technician calling about a dog they are treating at their hospital. The dog presents with elevated liver and kidney enzymes, increased white blood cell count, lethargy, and has vomited once. The dog's owner sprayed diluted product along his kitchen baseboards and walls 5 days ago. The dog was kept out of the treated area until the product had dried thoroughly, and no exposure was witnessed. 11/7/2014 Attempted call back to the treating hospital. A message was left requesting follow up information. 11/10/2014 Call back from the treating hospital. The dog's renal and liver values continued increasing, white blood cell count continued increasing, and a urinalysis showed a lot of bacteria. The dog was treated with aggressive intravenous fluids and antibiotics, but died several days later. The veterinarian thought it could be leptospirosis or ascending nephritis, but the diagnosis was left open. The veterinarian did not think the symptoms were related to the use 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