BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20

    MDR report key: 2091658 · Received April 28, 2011

    Report

    Report Number
    3003768277-2011-00342
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SERIOUS INJURY. PT FELL FROM TABLE AND WAS INJURED ON HEAD AND FACE. THE PT FELL FROM THE TABLE WHEN CUSTOMER WAS REMOVING THE ARM SUPPORT FROM UNDER THE TABLE MATTRESS. THE CUSTOMER WAS USING TOWELS AND NOT THE ARM SUPPORT PAD. ALSO PT WAS NOT SECURED TO THE TABLE IN ANY WAY, BUT SLID TO THE SIDE WHEN REMOVING THE ARM SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI, MBQ IZI PHILIPS HEALTHCARE 722006

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization