BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP BAND

    MDR report key: 7112222 · Received December 12, 2017

    Report

    Report Number
    MW5073949
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    December 10, 2015
    Report Date
    December 10, 2017
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY BODY STARTED SWELLING AND BUILDING INFECTION. WENT TO DR AND DONE TEST AND TOLD ME I HAD AN EROSION (IN LESS THAN A YEAR OF IMPLANT) AND IMMEDIATELY SET THE SURGERY DATE FOR NEXT DAY. AFTER SURGERY, DR HAD SAID THAT THIS WAS THE MOST INFECTION IN A BODY HE HAD EVER SEEN, AND IF I HAD WAITED ANY LONGER, IT COULD HAVE BEEN FATAL. I WAS SEDATED FOR 4 DAYS I HAD NO IDEA I WAS EVEN IN THERE. WHEN I WOKE UP MY HUSBAND TOLD ME WE BEEN IN THERE 4 DAYS ALREADY. I HAD 1 IV'S RUNNING IN ME AS WELL AS A DRAIN TUBE FROM MY BELLY. I STAYED IN THERE ANOTHER 4 DAYS BEFORE I WAS ABLE TO GO HOME. SINCE THAT DAY I CONTINUE TO HAVE A LOT OF STOMACH PAIN, STOMACH ISSUES, DEPRESSION FROM THIS BECAUSE I FELT LIKE A FAILURE, AND I AM HAVING WEIGHT ISSUES AGAIN BUT SCARED TO DEATH TO TRY A DIFFERENT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886481 LAP BAND LAP BAND LTI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R