BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA II PENILE IMPLANT

    MDR report key: 82350 · Received April 4, 1997

    Report

    Report Number
    2082063-1997-90003
    Event Type
    Other
    Date Received
    April 4, 1997
    Date of Event
    January 8, 1997
    Report Date
    April 4, 1997
    Manufacturer
    UROHEALTH SYSTEMS, INC.
    Product Code
    FAE
    Removal / Correction Number
    UNK
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR WEEKS AFTER IMPLANTING PROSTHESIS, IT BEGAN TO ERODE. THE RIGHT CYLINDER OF THE IMPLANT WAS REMOVED AND THE LEFT CYLINDER REMAINS IN PLACE. PT TO HAVE NEW IMPLANT ON RIGHT SIDE AFTER 3 MONTHS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA II PENILE IMPLANT Implant MALLEABLE PENILE PROSTHESIS FAE UROHEALTH SYSTEMS, INC. * 96026D1024

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention