BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 62779 · Received January 2, 1997

    Report

    Report Number
    2126328-1996-06132
    Event Type
    Injury
    Date Received
    January 2, 1997
    Date of Event
    November 22, 1996
    Report Date
    January 2, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 4/15/92 AN IPP DEVICE WAS IMPLANTED. ON 7/13/92 THE CYLINDERS AND PUMP WERE REPOSITONED. ON 11/22/96 THE IPP DEVICE WAS REMOVED FROM THE PT DUE TO FLUID LOSS-RIGHT CYLINDER. ANOTHER DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 9680M 001, 9680M 001

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R