BEUDAMED
    FDA Adverse Event Other Summary report: N

    TITAN SCROTAL BIOFLEX CYLINDER SET WITH PUMP

    MDR report key: 555267 · Received November 16, 2004

    Report

    Report Number
    555267
    Event Type
    Other
    Date Received
    November 16, 2004
    Date of Event
    September 28, 2004
    Report Date
    October 20, 2004
    Manufacturer
    MENTOR
    Product Code
    FHW
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INCOMPLETE PARA T-12 TO II SINCE 1993 WITH ERECTILE DYSFUNCTION HAD A PENILE PROSTHESIS WHICH MALFUNCTION AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN SCROTAL BIOFLEX CYLINDER SET WITH PUMP MENTOR PENILE PROSTHESIS FHW MENTOR 3X2 792588

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other