BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 4890856 · Received July 1, 2015

    Report

    Report Number
    1722684-2015-00003
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 26, 2015
    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, HOWEVER WE ARE ATTEMPTING TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT. IN ADDITION, THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION. THIS IS A PRELIMINARY REPORT INSIDE THE 30-DAY REPORT WINDOW. THIS WILL BE AMENDED AS NECESSARY.

    Description of Event or Problem · 1

    THE OBSTETRICIAN FILLED THE UTERINE BALLOON WITH 500 ML ISOTONIC SOLUTION TO STOP PPH AND AFTER THE PROCEDURE THE MOTHER WAS TRANSFERRED IN RECOVERY ROOM. AFTER 2 HOURS, THE MIDWIFE NOTICED THAT THE UTERINE BALLOON WAS COMPLETELY DRAINED OUT OF WATER AND TOTALLY EMPTY WITHOUT ANY VISIBLE REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429471 EBB COMPLETE TAMPONADE SYSTEM EBB COMPLETE TAMPONADE SYSTEM OQY CLINICAL INNOVATIONS, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK