BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 4976080 · Received August 4, 2015

    Report

    Report Number
    1722684-2015-00006
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 8, 2015
    Report Date
    August 3, 2015
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    OQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. DEVICE RETURNED. COMPLAINT CONDITION CONFIRMED, BALLOON MATERIAL HAD SEPARATED FROM DEVICE.

    Description of Event or Problem · 1

    "UPON INFLATION W/FLUID, THE UTERINE BALLOONS WAS DISCOVERED TO BE LEAKING. IT WAS REMOVED AND A BAKRI DEVICE WAS PLACED. THE PT. DID NOT HAVE ANY UNTOWARD EFFECTS & WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509601 EBB COMPLETE TAMPONADE SYSTEM EBB COMPLETE TAMPONADE SYSTEM OQY CLINICAL INNOVATIONS, LLC 1214-F-403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization