Malleable Reported Events - January 2026 Updates from MAUDE DB

[lasthope2.0]

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

[duke_cicero]

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

I wonder how long it takes to register these events in the system. I do wonder if the "one device not replaced" is our old friend on the forum. I hope he's doing okay.

[JohnnyBorg]

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

I wonder how long it takes to register these events in the system. I do wonder if the "one device not replaced" is our old friend on the forum. I hope he's doing okay.

As I’ve been healing up I’ve been thinking about Mark1974 a lot actually, also hope he’s doing okay. He actually popped into my malleable journal with a question the other day, which was nice to see. Even though the MPP didn’t work out for him, I still wonder if an IPP could be in the cards for him down the line, could possibly be the right fit for him in terms of flaccid state comfort.

[lasthope2.0]

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

I wonder how long it takes to register these events in the system. I do wonder if the "one device not replaced" is our old friend on the forum. I hope he's doing okay.

Good catch, Duke. Sometimes older events are reported late. I hope he is doing well. I wish there were some kind of comfortable, foam-like corporal space saver, so people could always opt for an implant years down the line after a removal.

[duke_cicero]

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

I wonder how long it takes to register these events in the system. I do wonder if the "one device not replaced" is our old friend on the forum. I hope he's doing okay.

Good catch, Duke. Sometimes older events are reported late. I hope he is doing well. I wish there were some kind of comfortable, foam-like corporal space saver, so people could always opt for an implant years down the line after a removal.

Sounds like a patentable idea...

[Thisworld]

I wonder how long it takes to register these events in the system. I do wonder if the "one device not replaced" is our old friend on the forum. I hope he's doing okay.

Good catch, Duke. Sometimes older events are reported late. I hope he is doing well. I wish there were some kind of comfortable, foam-like corporal space saver, so people could always opt for an implant years down the line after a removal.

Sounds like a patentable idea...

That wuold be: Subrini ssda / virilis I