BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAC-PAC

    MDR report key: 618984 · Received June 9, 2005

    Report

    Report Number
    618984
    Event Type
    Injury
    Date Received
    June 9, 2005
    Date of Event
    April 8, 2005
    Report Date
    June 9, 2005
    Manufacturer
    OLYMPIC MEDICAL CORP.
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LARGE BODY MASS PATIENT WAS HAVING AN OPEN REDUCTION WITH INTERNAL FIXATION ON THE RIGHT WRIST. THE PATIENT WAS POSITIONED IN THE LEFT LATERAL POSITION ON THE BEAN BAG AND THE AIR WAS SUCTIONED OUT OF THE BAG. A BLANKET WAS PLACED AT THE BASE OF THE PAD BUT NOTHING WAS BETWEEN THE PATIENT AND THE PAD. A PILLOW WAS ALSO PLACED BETWEEN THE PATIENT'S LEGS AND GEL PADS UNDER THE PATIENT'S LEG WHICH WAS IN CONTACT WITH THE TABLE. PART WAY THROUGH THE PROCEDURE, THE PATIENT WAS MOVED ON THE TABLE TO FACILITATE SURGERY WITHOUT UNDRAPING OR RECHECKING THE POSITION. AT THE END OF CASE, A RED SPOT NOTED ON PATIENT'S LEFT THIGH AND THE PATIENT COMPLAINED OF PAIN AT THE SITE. DIAGNOSED WITH COMPARTMENT SYNDROME THE NEXT MORNING SUSPECTED TO BE FROM THE PATIENT'S TOP LEG WEIGHTED ON THE LOWER LEG ALONG WITH THE PRESSURE FROM THE EDGE OF THE AIR BAG. FASCIOTOMIES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAC-PAC BEAN BAG POSITIONING DEVICE CCX OLYMPIC MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R