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Journal Article
Are complications reported in clinical studies just the tip of the iceberg?
2024
Overview
In their study, Lombardo et al. provide an evaluation of adverse events associated with ureteral stents, as catalogued in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database over the past decade [1]. In use since the 1990s and not designed for academic research purposes, submissions to MAUDE are often incomplete and lack information on hospital settings or surgeon experience. In this context, MAUDE’s anonymous nature becomes a crucial advantage, offering an unfiltered look into adverse events. [...]MAUDE deserves recognition, and its merits should be expanded upon.
Publisher
Springer Berlin Heidelberg,Springer Nature B.V
Subject
