BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALLOON PUMP

    MDR report key: 6124736 · Received November 21, 2016

    Report

    Report Number
    MW5066283
    Event Type
    Other
    Date Received
    November 21, 2016
    Date of Event
    June 20, 2013
    Report Date
    November 21, 2016
    Product Code
    DSP
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BALLOON PUMP INCORRECTLY INSTALLED BY UNTRAINED PA CAUSING BLOOD FLOW TO LOWER BODY TO BE CUT OFF. THIS LED TO THE AMPUTATION OF RIGHT FOOT AND DECREASED BLOOD FLOW TO LEFT LEG AND FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767995 BALLOON PUMP BALLOON PUMP DSP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other ATORVASTATIN| CARVEDILO| FUROSEMIDE| LISINOPRIL| PACE RONE| PANTOPPRAZOLE| WARFARIN