BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILER BALLOON

    MDR report key: 2013472 · Received March 7, 2011

    Report

    Report Number
    MW5019695
    Event Type
    Other
    Date Received
    March 7, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ANGIO DYNAMICS
    Product Code
    LIT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN PREPARING TO USE THE CATHETER, IT WAS NOTED THAT THE BALLOON IN THE PACKAGE WAS NOT THE SAME SIZE AS LABELED ON THE PACKAGE. ALL CATHETERS WERE REMOVED FROM IR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILER BALLOON LIT ANGIO DYNAMICS 16801105
    2 PROFILER BALLOON LIT ANGIO DYNAMICS 16801101

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR