BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON GASTRIC BALLOON

    MDR report key: 10378605 · Received August 6, 2020

    Report

    Report Number
    MW5095931
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 4, 2020
    Manufacturer
    OBALON THERAPEUTICS, INC
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OBALON GASTRIC BALLOON DEFLATED AND MIGRATED THROUGH GI TRACT. CT SCAN OBTAINED SHOWED NO EVIDENCE OF BALLOON SO THE PATIENT MUST HAVE SPONTANEOUSLY PASSED THE BALLOON. PT NEVER HAD ANY SYMPTOMS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841287 OBALON GASTRIC BALLOON IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBALON THERAPEUTICS, INC OBALON BALLOON 190326401

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR