| Event Confirmed |
Select Yes if the event is confirmed.
Otherwise, select No. Note:
You must be a Quality Manager
to edit this field.
|
Public Health Threat | Select Yes if the problem is a public health threat. Otherwise, select No. |
Medical | Select Yes if the event is confirmed. Otherwise, select No. Note:
This field is not editable if the event is reportable.
|
Product Problem | Select Yes if the problem was caused by product malfunction. Otherwise, select No. |
Reportable Status | Select a reportable status for the event. You can select Not Reportable, Reportable, Other, or Unknown. Note:
This field is not editable if the event is not medical.
|
Reportable Rationale | Type the reason if you designate the event as reportable |
Event Classification | Timing | Select the process during which the problem was identified. You can select
Kit Inspection, Other,
Unknown, or Upon
Receipt. Note:
You must be the event originator or a Quality
Manager to edit this field.
|
Event Information | Event Details | Describe the details of the event. Note:
You must be the event originator or a
Quality Manager to edit this field.
|