Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-2696
2. Registrant Information.
Registrant Reference Number: 1617572
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.
31-MAY-15
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. Unknown
Product Name: Unspecified Bayer Fungicide
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 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: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Gastrointestinal System
- Symptom - Anorexia
- Symptom - Irritated throat
- Liver
- Symptom -
- Specify - Swollen liver
- Blood
- Symptom - Other
- Specify - Swollen spleen
- Respiratory System
- Symptom - Shortness of breath
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?
Unknown
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)
Unknown
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.)
5/31/2015 Caller states that the product was applied in her brother's home some time between 2 to 4 weeks ago. About 2 weeks ago, he developed a sore throat and went to his doctor. The doctor found that his throat was inflamed, and prescribed an antibiotic. The sore throat persisted, and he went back to the doctor on 5/27/2015 or 5/28/2015. By this time he had also lost his appetite and was losing weight. He went to the emergency room on 5/29/2015. No diagnosis was given, and he was admitted to the hospital. He was given intravenous fluids and antibiotics. He is having his heart checked, and was given a computerized tomography scan last night, and the results are pending. His temperature this morning was 107 degrees Fahrenheit, his liver and spleen are swollen, and he is having difficulty breathing. 6/4/2015 Call back attempted to the original caller. A message was left requesting follow up information. 6/5/2015 Call back attempted to the original caller. A message was left requesting follow up information.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.