Learn how to extend Case-level Seriousness options to support Device and Combination Product Cases.
About the Feature
With the 24R1 release, to support migrating Device and Combination Product Cases, you can update the Case- and Adverse Event-level Seriousness picklist to include Required Intervention to Prevent Permanent Impairment/Damage (Devices). This feature includes the new Seriousness picklist value only. Future enhancements will include mapping the value for report generation.
For more information about migrating Cases, see Migrate External Cases.
Update the Seriousness Picklist
Complete the following steps to update the Seriousness picklist to include Required Intervention to Prevent Permanent Impairment/Damage (Devices):
- Go to Admin > Settings > Application Settings > Safety General Settings.
- Select Edit.
- In the Other Options section, select the Extend Seriousness to include Required Intervention to Prevent Permanent Impairment/Damage (Medical Device/Combination Products Only) checkbox.
- Select Save.
Result
When processing Cases with Device or Combination Products, the Case- and Adverse Event-level Seriousness picklist includes Required Intervention to Prevent Permanent Impairment/Damage (Devices).