BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS ELITE

    MDR report key: 487905 · Received October 6, 2003

    Report

    Report Number
    487905
    Event Type
    Injury
    Date Received
    October 6, 2003
    Date of Event
    April 1, 2003
    Report Date
    June 1, 2003
    Manufacturer
    TRULIFE
    Product Code
    KME
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT A MULTI-LEVEL LUMBAR SPINE FUSION AND WAS PRONE FOR APPROXIMATELY 8 HOURS ON A JACKSON TABLE. THEIR FACE WAS PADDED WITH A GEL RING. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THERE WAS AN AREA OF INDENTATION ON THE PT'S FOREHEAD. THE SKIN BROKE DOWN IN THE AREA, AND IT IS UNDETERMINED WHAT THE ULTIMATE COSMETIC RESULT WILL BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASIS ELITE PRONE HEADREST KME TRULIFE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other