BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 74679 · Received March 5, 1997

    Report

    Report Number
    2126328-1997-00964
    Event Type
    Other
    Date Received
    March 5, 1997
    Date of Event
    January 30, 1997
    Report Date
    March 5, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CYLINDERS AND PUMP WERE REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 6757P 007,6575P 007,6757P 007

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R