Malleable Reported Events - January 2026 Updates from MAUDE DB

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Malleable Reported Events - January 2026 Updates from MAUDE DB

Coloplast Genesis (2 Events):
-Infection (including one case with a fluid-filled mass).
-100% explanted.
-One device not replaced.

Boston Scientific Tactra (4 Events):
-Concealability
-Sizing issues
-Penile pain/discomfort
-Unspecified revision
-100% explanted or revised
-Some replaced with an IPP


https://www.fda.gov/medical-devices/med ... data-files