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Serious Injury In Box H1(Medwatch Report) Should Be Checked for Serious Medical Device Cases (Doc ID 2031064.1)

Last updated on FEBRUARY 21, 2019

Applies to:

Oracle Argus Safety - Version 7.0.3 and later
Information in this document applies to any platform.


In the MedWatch report, the Serious Injury check box in Box H1 'Type of Reportable Event' should always be ticked for a serious medical device case regardless of the seriousness criteria selected for the case.  This is not happening correctly in Argus 7.0.3.

The current logic says: Serious Injury in Box H1 is checked if 'Hospitalised' or 'Life Threatening' is checked in the case.

It is not acceptable to select the 'Hospitalised' or 'Life Threatening' seriousness criteria in the case just to have Serious Injury checked in H1.  This will also result in section B2 having incorrect/discrepant information.

How can the mapping be changed to check the Serious Injury check box in Box H1 for serious medical device cases?


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