Before revision: Grades are defined:Common Terminology Criteria for Adverse Events Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Database of adverse events The FDA provides a database for reporting of adverse events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1].
After revision: Grades are defined:Common Terminology Criteria for Adverse Events Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE DatabasesDevicesdevice of adverse events The FDA provides a database for reporting of adverse events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1].