BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 4379626 · Received December 29, 2014

    Report

    Report Number
    1722684-2014-00004
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    October 24, 2014
    Report Date
    December 29, 2014
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    OQY
    PMA / PMN Number
    K091958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. PT HAD STABILIZED AT TIME MALFUNCTION WAS NOTED. DEVICE DISCARDED, NO EVAL COULD BE PERFORMED.

    Description of Event or Problem · 1

    BALLOON WAS FILLED WITH 700MLS AND 'ROSE COULOURED WATER' WAS NOTICED COMING FROM THE DRAINAGE LUMEN. WHEN HE WENT TO EMPTY THE UTERINE BALLOON, ONLY 20MLS REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855487 EBB COMPLETE TAMPONADE SYSTEM EBB COMPLETE TAMPONADE SYSTEM OQY CLINICAL INNOVATIONS, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK