BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2861210 · Received November 7, 2012

    Report

    Report Number
    2861210
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MIZUHO AMERICA INC.
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS THE PATIENT WAS BEING TRANSFERRED OUT OF TRACTION, HER WELL LEG WAS BEING REMOVED FROM THE WELL LEG HOLDER. SHE SLIPPED THROUGH THE MIDDLE PORTION OF THE FRACTURE TABLE, FELL TO THE FLOOR, AND HIT HER HEAD. THE PATIENT WAS UNCONSCIOUS AND INTUBATED WHEN THE FALL OCCURRED.ANESTHESIA AND HOSPITAL REPORTER WERE IMMEDIATELY NOTIFIED. THE PATIENT WAS PLACED IN A HARD CERVICAL COLLAR. SHE WAS LOG ROLLED ONTO A STRETCHER AND TRANSFERRED BACK TO THE FRACTURE TABLE. AT THIS POINT, WE OBTAINED FLUOROSCOPIC IMAGES OF HER RIGHT SHOULDER TO CONFIRM THAT THERE WAS NO DISPLACEMENT OR DISLOCATION. SHE WAS THEN EXAMINED. HER VITALS REMAINED STABLE. NO ADDITIONAL FRACTURES OR DEFORMITIES WERE APPRECIATED. SHE WAS TRANSFERRED TO A HOSPITAL GURNEY. SHE DID HAVE SWELLING OVER THE BACK OF HER HEAD. SHE WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM (PACU) IN STABLE CONDITION.THE PATIENT DID NOT HAVE A FRACTURE OR AN INTRACRANIAL BLEED DUE TO THIS FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TABLE, SURGICAL GDC MIZUHO AMERICA INC. 5803 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention OTHER