BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4CC LAP BAND

    MDR report key: 1170066 · Received September 21, 2008

    Report

    Report Number
    MW5008366
    Event Type
    Injury
    Date Received
    September 21, 2008
    Date of Event
    September 19, 2006
    Report Date
    September 21, 2008
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD GASTRIC LAP-BAND INSERTED IN 2006. DAY AFTER COMING HOME LANDED BACK IN HOSPITAL DUE TO MY BODY'S REACTION TO THE BAND AND INABILITY TO SWALLOW WATER. FOR A YEAR AFTER BAND WAS FINE. SINCE THEN THE BAND HAS NOW STARTED TO ERODE WITHIN 2 YEARS OF ORIGINAL SURGERY AND CAUSED ISSUES WITH MY ESOPHAGUS. HAVE ALREADY BEEN UNFILLED, AND DUE TO REACTION WITH THE BAND EVERY TIME I EAT OR DRINK I HAVE SEVERE PAIN ON THE RIGHT SIDE AND SWELLING; LOOKS LIKE HALF A GRAPEFRUIT IS STICKING OUT OF MY SIDE FOR 2-3 HOURS. ALSO HAD TO HAVE THE PORT MOVED IN 2007 FROM THE RIGHT SIDE TO THE LEFT SIDE AND HAD TUBING REPLACED. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: WEIGHT LOSS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4CC LAP BAND GASTRIC LAP BAND LTI
    2 GASTRIC LAP BAND GASTRIC LAP BAND LTI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O| S