BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON

    MDR report key: 5091025 · Received September 21, 2015

    Report

    Report Number
    3006722112-2015-00366
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, EXPLANT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF A DAMAGED DEVICE: WARNING: RAPID FILL RATES WILL GENERATE HIGH PRESSURE WHICH CAN DAMAGE THE ORBERA¿ SYSTEM VALVE OR CAUSE PREMATURE DETACHMENT. A BALLOON WITH A LEAKING VALVE MUST BE REMOVED IMMEDIATELY. A DEFLATED BALLOON CAN RESULTS IN A BOWEL OBSTRUCTION, WHICH CAN RESULT IN DEATH. BOWEL OBSTRUCTIONS HAVE OCCURRED AS A RESULT OF UNRECOGNIZED OR UNTREATED BALLOON DEFLATION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "VALVE DISENGAGED DURING BALLOON IMPLANTATION PROCESS." DEVICE WAS EXPLANTED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622201 ORBERA INTRAGASTRIC BALLOON IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ALLERGAN (COSTA RICA) 2675664

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other