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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2695

2. Registrant Information.

Registrant Reference Number: 1606362

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.

13-MAY-15

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

13-MAR-15

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. 432-1457

Product Name: Coretect Tree and Shrub Insecticide

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 20 %

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. - 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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Coughing
    • Symptom - Respiratory distress
    • Specify - COPD
    • Symptom - Pneumonia
    • Symptom - Bronchitis

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?

1

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Application

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>1 mo <=2 mos / > 1 mois < = 2 mois

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.)

5/13/2015 Caller states that sometime in March 2015 her husband made holes in the yard and had her put the product in the holes. She was not wearing gloves at the time. On May 10, 2015 caller developed a cough. She went to the emergency department in the early morning on May 11, 2015. An x-ray was done, and she was found to have pneumonia. She was given oxygen and intravenous antibiotic and prednisone. She was also given a bronchodilator nebulizer treatment. She was admitted for further evaluation. While she was in the hospital, caller was evaluated by a lung specialist who indicated that she had bronchitis and newly diagnosed chronic obstructive pulmonary disease. She was discharged home on May 12, 2015 with an inhaler, oral antibiotics, and instructions to quit smoking. She has a follow up appointment with her regular doctor on May 14, 2015. 5/20/2015 Call back to the original caller for follow up information. She is much improved now. She will see her doctor again in one month for a follow up.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.