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 Databases of adverse events Devices The FDA provides a database for reporting of adverse device 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 Databases of adverse events Medical devicesmedical The FDA provides a database for reporting of adverse device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1].