BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND

    MDR report key: 3872186 · Received June 9, 2014

    Report

    Report Number
    MW5036560
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ALLERGAN LAPBAND PLACED IN 2003 AND WAS NOT MADE AWARE OF THE MAJOR COMPLICATIONS THAT COULD ARISE OVER TIME WITH THE DEVICE. SINCE PLACEMENT IN HAVE BEEN IN PAIN DAILY, SUFFERED SEVERE GERD, MY ESOPHAGUS IS DILATED, MY STOMACH IS STRETCHED SO THIN IT CAN NOT BE REPAIRED UNTIL LATER DATE. I AM HAVING IMMEDIATE SURGERY IN 3 DAYS TO HAVE IT REMOVED AS IT HAS BECOME LIFE THREATENING DUE TO ESTRANGULATION OF THE STOMACH TISSUE AT THE BAND SITE. THIS DEVICE SHOULD BE BANNED. MY COMPLICATIONS ARE DUE TO THE DEVICE SLIPPING OUT FROM ITS SURGICAL PLACEMENT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334241 LAP-BAND LAP-BAND LTI ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O| R