Downgrade Needs To Be Scheduled Instead Of Nullification (Doc ID 2278871.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

Downgrade E2B and PMDA Form reports are required to be scheduled after Initial E2B was submitted and case Product is changed to another Company Product and Event becomes Non-reportable.
Downgrade E2B and PMDA Form reports should be scheduled in the following SCENARIO-A and SCENARIO-B.

SCENARIO-A:

1) Submit Initial report with Company Product and one Serious Event and one Non-serious Event.
2) Unlock the case as significant follow-up, change the Product to another Company Product, and delete Serious Event only.
3) Auto-schedule. ---> Nullification report for the original Product's license is scheduled. ===> Downgrade is expected.

SCENARIO-B:

1) Submit Initial report with Company Product and one Reportable Event.
2) Unlock the case as significant follow-up, change the Product to another Company Product and change Event Causality from Y to N.
3) Auto-schedule. ---> Nullification report for the original Product's license is scheduled. ===> Downgrade is expected.

Changes

Cause

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