BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP BAND

    MDR report key: 4190176 · Received October 14, 2014

    Report

    Report Number
    MW5038678
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    December 24, 2012
    Report Date
    October 14, 2014
    Manufacturer
    ALLERGEN
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE ALLERGAN LAP BAND HAS CAUSED A STOMACH ULCER POSSIBLE EROSION WAITING ON THE DEVICE TO BE REMOVED (B)(6). I WAS HOSPITALIZED (B)(6) 2012 WITH COMPLICATIONS AND HAVE BEEN FIGHTING WITH MY INSURANCE TO HAVE THE PRODUCT REMOVED. IT IS PAINFUL AND HAD BECOME INEFFECTIVE FINALLY GETTING THE BAND REMOVED. THE BAND WAS IMPLANTED IN (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649741 LAP BAND GASTRIC BANDING SYSTEM LTI ALLERGEN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R