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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-5889
2. Registrant Information.
Registrant Reference Number: 1246876
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.
15-SEP-135. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
15-AUG-13Product 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 Advance 12 month tree and shrub protect and feed concentrate II
- Active Ingredient(s)
- CLOTHIANIDIN
- Guarantee/concentration .37 %
- IMIDACLOPRID
- Guarantee/concentration .74 %
- CLOTHIANIDIN
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?
YesSubform 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
- General
- Symptom - Malaise
- Respiratory System
- Symptom - Pneumonia
- Symptom - Respiratory failure
- Symptom - Dyspnea
- General
- Symptom - Chills
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?
12
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.
Skin
11. What was the length of exposure?
<=15 min / <=15 min
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.)
9/15/2013: Caller states that her father applied product around his trees on Aug. 16 or 17. The caller states that the wind had blown diluted product back on him but she doesn't know when he washed off. An unspecified period of days later he developed chills. An unspecified period of days after developing chills, he developed dyspnea. After another 5 to 7 days, he eventually saw his heart surgeon who immediately admitted him to a hospital on Sept. 3. Due to his lack of oxygenation, he was intubated and has been on a ventilator since. There has been a series of test run (type of test and results unk) and a number of specialist (pulmonologist, infectious disease ect) but there is no diagnosis at this time although they stated that he had pneumonia. The patient had a history of cardiac arrhythmias for which he was recently treated with cardiac ablation therapy and the placement of a pacemaker. The caller was not able to provide a date on which this was done but she knows that it was sometime in August.
To be determined by Registrant
14. Severity classification.
Major
