Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-5170
2. Registrant Information.
Registrant Reference Number: 2609393
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.
10-FEB-20
5. Location of incident.
Country: CANADA
Prov / State: ALBERTA
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. 32524
PMRA Submission No.
EPA Registration No.
Product Name: TEMPRID SC INSECTICIDE
- Active Ingredient(s)
- BETA-CYFLUTHRIN
- Guarantee/concentration 10.5 %
- IMIDACLOPRID
- Guarantee/concentration 21 %
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: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
4. How long did the symptoms last?
Unknown / Inconnu
5. Was medical treatment provided? Provide details in question 13.
No
6. a) Was the person hospitalized?
No
6. b) For how long?
Unknown
7. Exposure scenario
Non-occupational
8. How did exposure occur? (Select all that apply)
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
Other
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?
>1 wk <=1 mo / > 1 sem < = 1 mois
12. Time between exposure and onset of symptoms.
>3 days <=1 wk / >3 jours <=1 sem
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.)
2/10/2020 Caller has this product applied in her home approximately 2 weeks ago. Around 1 week later, her boyfriend developed hives on his abdomen. Caller had her house sprayed again with the product today. Caller's boyfriend has not done anything for treatment. He still has the hives and has not developed any new symptoms. Caller says that her boyfriend followed the company's instructions and stayed out of the house for 6 hours, and caller does not think that her boyfriend came into contact with the product. 2/11/2020 Attempted call back to the original caller. A message was left requesting follow up information.
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.
Given the hives did not appear until a week later with no known contact with the product a temporal relationship does not exist. Once the product is dried it is not expected to transfer from touch. All other differential diagnoses and causes have not been ruled out. Signs and symptoms did not abate with decontamination. The product was being reapplied the day of the call but is not considered a re-challenge as initial symptoms had not abated.