Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-3022
2. Registrant Information.
Registrant Reference Number: 1146600
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.
09-APR-13
5. Location of incident.
Country: UNITED STATES
Prov / State: FLORIDA
6. Date incident was first observed.
08-APR-13
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. 72155-80
Product Name: Home Pest plus Germ Killer Indoor & Outdoor Killer RTU (1 Gal)
- Active Ingredient(s)
- CYFLUTHRIN
- Guarantee/concentration .05 %
- SODIUM 2-PHENYLPHENATE
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. - 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.
Data Subject
2. Demographic information of data subject
Sex: Male
Age: >64 yrs / > 64 ans
3. List all symptoms, using the selections below.
System
- Gastrointestinal System
- Symptom - Tongue swelling
- Symptom - Salivating excessively
- Nervous and Muscular Systems
- Symptom - Difficulty talking
- Specify - difficulty speaking
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
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.
Respiratory
11. What was the length of exposure?
<=15 min / <=15 min
12. Time between exposure and onset of symptoms.
>8 hrs <=24 hrs / > 8 h < = 24 h
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.)
April 9, 2013 Caller states he used the product on April 8 and states while spraying the product on his window sills he feels like he may have inhaled the product, but he does not believe any product was ingested. The caller stated that on April 9 it felt as if his tongue was swollen and he is having difficulty speaking and feels he has increased salivation and slight hoarseness. The caller was instructed to seek a medical evaluation immediately.
Follow-up was completed with the consumer on April 15. The consumer confirmed that he ended up being hospitalized for one day and diagnosed with a minor stroke. He confirmed that his treating physicians ruled out the involvement of the pesticide.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.