BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE WIRE SENSOR

    MDR report key: 504785 · Received December 18, 2003

    Report

    Report Number
    8030904-2003-00008
    Event Type
    Malfunction
    Date Received
    December 18, 2003
    Date of Event
    November 19, 2003
    Report Date
    December 10, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE WIRE SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 12004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CATHETER.| BOSTON SCIENTIFIC 3.5 QUAUTUM MAVERICK BALLOON