MedWatch Device Report Not Showing SUSPECT DEVICE In Section D (Doc ID 2933315.1)

Last updated on JULY 13, 2023

Applies to:

Goal

MedWatch Device report is not showing the SUSPECT DEVICE in section D when there is a drug and device combo product.
Both Drug and Device are added as suspect but the device is not related and unlisted, in this scenario it does not appear in the section D of MedWatch Device form.
However, when the device is suspect and also related and unlisted and serious, it shows in section D of the MedWatch form.
When checking the mapping document for the MedWatch form it says Block D is blank if device is NOT a suspect, but its blank even when we added device as suspect.
 

Solution

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