BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 LGX MS PUMP

    MDR report key: 1980294 · Received January 25, 2011

    Report

    Report Number
    1980294
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED TO HAVE AN EXCHANGE OF HIS PENILE IMPLANT THAT FAILED TO WORK. IT IS UNKNOWN HOW THIS EVENT OCCURRED. THE PRODUCT REP IS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 700 LGX MS PUMP 3 PIECE INFLATABLE PENILE IMPLANT FHW AMERICAN MEDICAL SYSTEMS 72404232 537987004

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NONE KNOWN