BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROFLEX PENILE PROSTHESIS

    MDR report key: 52078 · Received November 25, 1996

    Report

    Report Number
    2126328-1996-05510
    Event Type
    Injury
    Date Received
    November 25, 1996
    Date of Event
    July 2, 1992
    Report Date
    November 25, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 9/20/1989 A HYDROFLEX DEVICE WAS IMPLANTED. SOMETIME IN 1991 THE HYDROFLEX DEVICE WAS REMOVED FROM THE PT DUE TO "MALFUNCTION." ADDITIONAL INFO RECEIVED ON 12/9/1998 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PT DUE TO A NON-FUNCTIONING DEVICE ON 7/2/1992.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROFLEX PENILE PROSTHESIS Implant HPP FHW AMERICAN MEDICAL SYSTEMS, INC. HYDROFLEX 4415J 005, 4415J 006

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R