BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLURA XPER FD20

    MDR report key: 1317556 · Received February 6, 2009

    Report

    Report Number
    1217116-2009-00009
    Event Type
    Other
    Date Received
    February 6, 2009
    Date of Event
    January 15, 2009
    Report Date
    January 15, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP NOTIFIED PHILIPS THAT FOUR PTS RESULTED WITH HAIR LOSS FOLLOWING NEUROLOGY PROCEDURES ON THIS X-RAY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI (ANGIOGRAPHIC X-RAY SYSTEM) IZI PHILIPS MEDICAL SYSTEMS 722008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other