July 2025 IPP Adverse Events Reported to US FDA
Attached Excel and PDF files
Coloplast Titan - 142
AMS700 - 205
Total - 347
July 2025 - IPP Adverse Events
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July 2025 - IPP Adverse Events
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40, Jan 2025 - Coloplast Genesis 22-13.
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Re: July 2025 - IPP Adverse Events
interesting .
American , retired in the philippines .
tactra malleable 13 mm ,in new delhi India . on april 2024
tactra malleable 13 mm ,in new delhi India . on april 2024
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Re: July 2025 - IPP Adverse Events
LastHope wrote:July 2025 IPP Adverse Events Reported to US FDA
Attached Excel and PDF files
Coloplast Titan - 142
AMS700 - 205
Total - 347
The juicy monthly batch… May God stand by them, because neither the companies nor surgeons are willing to.
Also let’s not forget the ones who weren’t even reported and poor infla 10AX implantees.
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Re: July 2025 - IPP Adverse Events
Interesting reads, it would be nice if they gave more detail in the writeup, such as which pump was it, who the surgeons were, how long it had been implanted, etc..
Age 64, type 1 diabetic, Married 20+ years, Titan implant 23 cm 27Feb2019, Duke Medical Hospital, Dr Lentz, failed March of 2024, revision 25Jun24 AMS700 LGX 18cm 5rte's Dr Andrew Chang associated urology Raleigh NC, Rex Hospital
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Re: July 2025 - IPP Adverse Events
wilsonmill wrote:Interesting reads, it would be nice if they gave more detail in the writeup, such as which pump was it, who the surgeons were, how long it had been implanted, etc..
I agree, I wish we had more data on these.
I’ve attached a version that includes AMS pump details for some events under the "Brand Name" column. Clicking the Web Address opens the relevant webpage. By comparing the "Date Device Manufactured" and "Initial Date FDA Received", we can estimate the device’s lifespan from factory to explantation.
For example, the attached device most likely lasted 3–4 years (assuming it spent about one year on the shelf after manufacturing).
https://www.accessdata.fda.gov/scripts/ ... uence_no=1
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40, Jan 2025 - Coloplast Genesis 22-13.
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Re: July 2025 - IPP Adverse Events
tooyoung wrote:LastHope wrote:July 2025 IPP Adverse Events Reported to US FDA
Attached Excel and PDF files
Coloplast Titan - 142
AMS700 - 205
Total - 347
The juicy monthly batch… May God stand by them, because neither the companies nor surgeons are willing to.
Also let’s not forget the ones who weren’t even reported and poor infla 10AX implantees.
Good point. Infla 10AX won't be under FDA's radar until its official FDA approval.
40, Jan 2025 - Coloplast Genesis 22-13.
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