Research
Trends and incidence of reported events associated with ureteral stents: An analysis of the food and drug administration's Manufacturer and User Facility Device Experience (MAUDE) database
Author(s): Riccardo Lombardo*, Alessio Guidotti, Antonio Nacchia, Daniele Fiasconaro, Giuseppe Santoro, Matteo Romagnoli, Yazan al Salhi, Giorgio Franco, Antonio Franco, Giorgia Tema, Giorgio Guarnotta, Antonio Cicione, Andrea Tubaro and Cosimo de Nunzio
Background: To summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA).
Methods: The MAUDE database was analyzed for all MDRs relating to each FDA-approved ureteral stent for the last ten years. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data.
Results: Overall, 2652 repo.. View More»
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