Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-2912
2. Registrant Information.
Registrant Reference Number: Prosar case 1-16295335
Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation
Address: 870 Technology Way
City: Libertyville
Prov / State: Illinois
Country: USA
Postal Code: 60048
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
18-JUN-08
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
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.
Product Name: VectoBac (non-specific)
- Active Ingredient(s)
- BACILLUS THURINGIENSIS, SEROTYPE H-14
7. b) Type of formulation.
Application Information
8. Product was applied?
Unknown
9. Application Rate.
10. Site pesticide was applied to (select all that apply).
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
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: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Skin
- Symptom - Itchy skin
- Symptom - Skin sensitivity
4. How long did the symptoms last?
Unknown / Inconnu
5. Was medical treatment provided? Provide details in question 13.
Unknown
6. a) Was the person hospitalized?
Unknown
6. b) For how long?
7. Exposure scenario
Occupational
8. How did exposure occur? (Select all that apply)
Other
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
10. Route(s) of exposure.
Unknown
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
>24 hrs <=3 days / >24 h <=3 jours
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.)
1-16295335: The reporter called on 6/18/08 to report possible exposure to a product containing the active ingredient Bacillus Thuringiensis subsp. israelensis. According to the reporter, she had become sensitive to the product after working with it for several years as part of mosquito control efforts. She stated that after being exposed to the product, she would develop a flesh eating disease. Although she no longer directly worked with the product, she had recently developed symptoms typical of those she used to have while working with it. Specifically, the reporter complained she had developed severe pruritis, swollen knees, and extremely sensitive skin. Per the reporter, she could not move due to the degree of swelling. The reporter speculated that personnel in the mosquito control crew had touched a surface that she had then subsequently touched. She felt stronger warnings and mandatory personal protective equipment should be required. The reporter stated she had been working with a physician regarding treatment for her symptoms. She inquired about additional treatment recommendations, and a recommendation was made to continue to work with her physician on this issue.
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.