Why Are Listed Events Appearing Under the Unlisted Section of the Summary Tabulation by System Organ Class (SOC) of PADER report for All Events Reported? (Doc ID 2948717.1)

Last updated on JULY 31, 2023

Applies to:

Symptoms

    1. Create a new case with License# A and 2 events.
    2. Calculate the event assessment/listedness as "listed" for both events with respect to License# A.
    3. Schedule a report to FDA destination.
    4. Reselect the product in case with license# B and recalculate the event assessment accordingly.
    5. Generate and submit the report scheduled in step 3.
    6. Generate a PADER line listing report for license# A and observe that both the events are appearing as Unlisted under Tabulation.

Listed events appearing under the Unlisted section of the Summary Tabulation by System Organ Class (SOC) of PADER report for All Events that were previously assessed as Listed.

Changes

Cause

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