BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED CONTROL MODULAR BASE

    MDR report key: 2921432 · Received January 9, 2013

    Report

    Report Number
    2921432
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 9, 2013
    Manufacturer
    OSI/MIZUHO
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN PRONE POSITION FOR 14 HOUR SPINE SURGERY ON THE JACKSON OSI TABLE. EXTRA PADDING PLACED AROUND BONY PROMINENCES. THE PATIENT WAS POSITIONED BY SURGEON AND OPERATING ROOM (OR) STAFF. AFTER SURGERY, THE PATIENT SUSTAINED SERIOUS DEEP TISSUE INJURY IN 11 LOCATIONS ON THE BODY, INCLUDING ACROSS THE ANTERIOR CHEST/TORSO, BILATERAL THIGH AND GROIN AREAS, BILATERAL SHINS, AND HEELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12606 ADVANCED CONTROL MODULAR BASE TABLE, SURGICAL BWN OSI/MIZUHO 5803 4957

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R OTHER