BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 18828199 · Received March 4, 2024

    Report

    Report Number
    2124215-2024-12656
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 7, 2024
    Report Date
    March 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953005744
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. THE PATIENT STATED THAT THERE IS A BULGING AT THE BASE OF THE PENIS ON THE LEFT SIDE WHEN INFLATING THE IPP. MEDICAL EXAMINATION WAS PERFORMED, AND IT WAS NOTED THAT THERE IS A FLACCID AREA ON THE LATERAL WALL OF THE CORPUS CAVERNOSUM WHEN THE LEFT CYLINDER IS PRESSED. A REVISION SURGERY HAS BEEN PLANNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695640 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404303 0176260004 00878953005744

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male RESERVOIR: UPN: 720185-01 / LOT: 1000160127