BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTPARTUM BALLOON

    MDR report key: 1980164 · Received February 1, 2011

    Report

    Report Number
    MW5019254
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 1, 2011
    Manufacturer
    COOK OB/GYN
    Product Code
    KNA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TURNING STOPCOCK ON BAKRI BALLOON, THE CLEAR PLASTIC THAT THE WHITE STOPCOCK FITS INTO, BROKE AND THE STOPCOCK FELL OUT. PHYSICIAN WAS ABLE TO USE UMBILICAL CORD CLAMP TO KEEP THE FLUID IN AND THE BALLOON INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTPARTUM BALLOON BAKRI POSTPARTUM BALLOON KNA COOK OB/GYN U1974264

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other