BEUDAMED
    FDA Adverse Event Other Summary report: N

    7" GENTLETOUCH PILLOW

    MDR report key: 1023631 · Received March 31, 2008

    Report

    Report Number
    2921578-2008-00006
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LUMBAR LAMI W/FUSION PROCEDURE (6+ HOURS) THE PATIENT WAS RETURNED (TWO DAYS LATER) TO THE OPERATING ROOM FOR A SECONDARY PROCEDURE. IT WAS NOTED THAT THE PATIENTS FOREHEAD WAS RED AND SIGNS OF BLISTERING. PATIENT STATED THAT HE BELIEVED IT WAS THE RESULT OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7" GENTLETOUCH PILLOW PILLOW KME MIZUHO ORTHOPEDIC SYSTEMS, INC. 1937

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization JACKSON SPINAL TABLE SYSTEM| ADVANCED CONTROL BASE