BEUDAMED
    FDA Adverse Event Summary report: N

    PROSTHESIS, PENILE, AMS 18CM ULTREX

    MDR report key: 2032571 · Received March 11, 2011

    Report

    Report Number
    2032571
    Date Received
    March 11, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Report Source
    User Facility report
    Reporter Location
    GA, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A REMOVAL OF A MALFUNCTIONING AMS 18CM ULTREX PENILE PROSTHESIS DUE TO AN EMPTY RESERVOIR. IT WAS IMPLANTED FOURTEEN YEARS AGO. THE IMPLANT WAS RETURNED TO THE MANUFACTURER. A NEW AMS 700 WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHESIS, PENILE, AMS 18CM ULTREX PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR