BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBALON BARIATRIC BALLOONS

    MDR report key: 7973535 · Received October 16, 2018

    Report

    Report Number
    MW5080604
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 14, 2018
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE OBALON BARIATRIC BALLOONS SWALLOWED 3 AND 5 WEEKS AGO. I HAD SERIOUS BOUTS OF VOMITING AND EXTREME STOMACH PAIN THE ENTIRE TIME. I LAID IN BED ALMOST THE ENTIRE PLACEMENT TIME WITH NAUSEA AND STABBING PAIN. DUE TO THIS I HAD TO HAVE THEM REMOVED ON (B)(6) 2018 AND NOW HAVE EXTREME PAIN STILL WHICH I AM DOUBLED OVER IN PAIN SEVERAL TIMES A DAY AS IF IT IS PERMANENT DAMAGE TO MY STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813048 OBALON BARIATRIC BALLOONS IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBALON THERAPEUTICS, INC. 7600-0001 180530404
    813049 OBALON BARIATRIC BALLOONS IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBALON THERAPEUTICS, INC. 7600-0001 180530404

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R| S