Fields
Section Name | Field Name | Description |
---|---|---|
Experience Code | Experience code that classifies the problem | |
Event Confirmed | Event confirmation status | |
Event Confirmed Date | Date when the event was confirmed | |
Medical | Medical status of the event | |
Public Health Threat | Is the event a public health threat | |
Product Problem | Is the problem caused by product malfunction | |
Reportable Status | Reportable status of the event. Possible values are Not Reportable, Reportable, Other, and Unknown. | |
Reportable Rationale | Reason for designating the event as reportable | |
Dates | Created Date | Date when the event occurred |
Modification Date | Date when event was last modified | |
Assignment | Owner | Name of event owner |
Originator | Name of event creator | |
Event Classification | Timing | Process during which the problem was identified. FDA codes for timing. Possible values are Kit Inspection, Other, Unknown, and Upon Receipt. |
Issue Code | Issue code that classifies the problem | |
Event Information | Event Details | Description of the event |