BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS THREE PART INFLATABLE PENILE PROSTHESIS

    MDR report key: 540453 · Received April 19, 2004

    Report

    Report Number
    540453
    Event Type
    Malfunction
    Date Received
    April 19, 2004
    Date of Event
    September 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAILED PENILE IMPLANT. A PT HAD A PENILE IMPLANT, AN AMS [AMERICAN MEDICAL SYSTEM INC] THREE PART INFLATABLE PENILE PROSTHESIS INSERTED AT ANOTHER HOSPITAL A NUMBER OF YEARS AGO. SINCE THE PT RECEIVED CRYOTHERAPY FOR BIOCHEMICAL FAILURE OF EXTERNAL BEAM RADIATION THERAPY, THE PT HAS HAD A NONFUNCITONING PENILE IMPLANT. THE PT [WAS] PRESENTED FOR EXPLANTATION OF A FAILED PENILE IMPLANT AND IMPLANTATION OF A NEW PENILE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS THREE PART INFLATABLE PENILE PROSTHESIS PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other NUMEROUS UROLOGIC PROCEDURES SINCE ORIGINAL| IMPLANTATION DUE TO PROSTATE CANCER.