Data Is Not Populating In Section H : US FDA MedWatch 3500A Device (Doc ID 2066574.1)

Last updated on MARCH 05, 2019

Applies to:

Symptoms

On Applications Oracle Argus Safety Version 8.0

Data is not populating in Section H "DEVICE MANUFACTURERS ONLY" of “US FDA MedWatch 3500A Device” report in 8.x

Even after following suggestions in the below note:

Note 1279053.1 - Section H Is Empty On The MedWatch 3500A Device Report

 Steps


1. Book-in a case
2. Go to Products tab.
3. Add a Product which is Device as well as Drug ( Ex; - PUREGON PEN).
4. Add 2 more products which are Drug and save the case.
5. Generate US FDA MedWatch 3500A Device report from the draft tool bar.
6. Section H is not getting populated.
7. Remove one of the drug product . Save the case.
8. Generate US FDA MedWatch 3500A Device report from the draft tool bar. This time section H is getting populated.

There is similar issue with Section D “SUSPECT MEDICAL DEVICE” . For this Oracle team has confirmed this as a Bug 21490841

Changes

Cause

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