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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6675

2. Registrant Information.

Registrant Reference Number: 1269128

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.

Human

4. Date registrant was first informed of the incident.

22-OCT-13

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. 72155-86

Product Name: All-In-One Lawn Weed and Crab Grass Killer - Concentrate

  • Active Ingredient(s)
    • 2,4-D (PRESENT AS AMINE SALTS : DIMETHYLAMINE SALT, DIETHANOLAMINE SALT, OR OTHER AMINE SALTS)
      • Guarantee/concentration 4.85 %
    • DICAMBA (PRESENT AS ACID, AMINE SALT, ESTER, OR SODIUM SALT)
      • Guarantee/concentration .45 %
    • QUINCLORAC
      • Guarantee/concentration 1.61 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - Out Home / Rés - à l'ext.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 II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Hypertension
  • Gastrointestinal System
    • Symptom - Sore throat
    • Symptom - Tongue swelling
  • General
    • Symptom - Pain
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Difficulty walking
  • Blood
    • Symptom - Hyperglycemia

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

28

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

October 22, 2013: Caller states that on the evening of 9/8/13, her husband applied the product from their hose to their yard. He does not recall any specific contact with the product. On the following day, he developed a sore throat that progressed to tongue swelling. He was taken to ER, where he was admitted to critical care unit for 15 days, most of which he spent under sedation, and then transferred to another area until 10/7/13. Caller believes he was treated with Prednisone, but she is unsure. He was then sent to a nursing home, where he currently remains. He is very weak and cannot walk, and is re-learning how to use his arms. He is being fed via a tube in his stomach, and requires insulin shots to control his blood sugar. With some progression, he has been able to take food orally as well. Follow-up on November 8, 2013: Caller states her husband is still in the nursing home unable to walk and is experiencing pain in his legs. He is eating food orally but still being supplemented via a stomach tube. The caller states the insulin shots are being continued as discussed on the initial call. The caller states her husband has been hypertensive and is wearing an unknown patch to lower his blood pressure. The doctors have not provided a diagnosis for his condition.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.