BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30MM BETA-CATH DELIVERY CATHETER

    MDR report key: 376259 · Received February 6, 2002

    Report

    Report Number
    1062385-2002-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2002
    Date of Event
    January 11, 2002
    Report Date
    February 6, 2002
    Manufacturer
    NOVOSTE CORP
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT THE PROXIMAL MARKER BAND ON THE CATHETER SHIFTED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30MM BETA-CATH DELIVERY CATHETER CATHETER MOU NOVOSTE CORP 510609-030 473662

    Patients

    Seq Age Sex Outcome Treatment
    1 *