Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0839
2. Registrant Information.
Registrant Reference Number: 1739036
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: 160 QUARRY PARK BLVD. SE Suite 200
City: CALGARY
Prov / State: AB
Country: Canada
Postal Code: T2C 3G3
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
17-DEC-15
5. Location of incident.
Country: CANADA
Prov / State: ALBERTA
6. Date incident was first observed.
16-DEC-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. 25673
PMRA Submission No.
EPA Registration No.
Product Name: TEMPO 20 WP INSECTICIDE (CANADA)
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.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: >64 yrs / > 64 ans
3. List all symptoms, using the selections below.
System
- Respiratory System
- Symptom - Respiratory irritation
- Symptom - Wheezing
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)
Contact with treated area
What was the activity? returned to the apartment approximately one week after product was applied and spent the night.
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?
>2 hrs <=8 hrs / >2 h <=8 h
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.)
12/17/2015 Product was used in her mother's apartment for bedbugs about 1 week ago. Her mother returned to the apartment yesterday and spent the night. She developed wheezing and respiratory irritation. She was taken to the emergency department, and admitted to the hospital. She has been given antibiotics and a steroid drip. She is on a bilevel positive airway pressure machine. She has had blood work, x-rays, and a computerized tomography scan. No test results are available. Neither caller nor her mother could smell the product in the apartment. 12/22/2015 Attempted call back to the original caller. A message was left requesting follow up information. 12/23/2015 Call back to the original caller for follow up information. Her mother is still in the hospital, but hopes to be released tomorrow. The doctor thinks the product may have caused a flare up of her mother's chronic obstructive pulmonary disease.
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.