BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAFLEX PENILE PROSTHESIS

    MDR report key: 90540 · Received May 9, 1997

    Report

    Report Number
    2126328-1997-02067
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    November 18, 1993
    Report Date
    May 9, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED 2/10/1998 INDICATES A REPLACEMENT OF HIS DEVICE ON 11/18/1993. THIS IS ALL THE INFO WE HAVE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAFLEX PENILE PROSTHESIS Implant DPP FHW AMERICAN MEDICAL SYSTEMS, INC. DYNAFLEX 0111Q 004 0111Q 028

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R| S