BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SST (500 LBS) W/GIMBALS & SHEARGUARD GE PADS W/MODULAR CART

    MDR report key: 3266564 · Received February 22, 2013

    Report

    Report Number
    2921578-2013-00004
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    December 29, 2010
    Report Date
    December 28, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO CONTACT COMPLAINANT, UNABLE TO CONFIRM DEVICE USED, CONDITION OF DEVICE, HOSPITAL WHERE INCIDENT OCCURRED. CLOSED DUE TO NO RESPONSE.

    Description of Event or Problem · 1

    DURING THE USE OF THE SPINAL TABLE, THE PT WAS TO HAVE FUSION ON T10 TO L5 ON THE SPINAL TABLE WITH FOAM FACE MASK FOR PRONE POSITION SURGERY. THE PT SUSTAINED SEVERE DEEP PRESSURE ULCERS TO THE CHIN REQUIRING PLASTIC SURGERY TO DEBRIDE ESCHAR, LEAVING LARGE 3CM PERMANENT SCARRING AND NUMBNESS OF THE CHIN AND FACE. THE PRESSURE ULCER WAS SO EXTENSIVE, IT TOOK 4 MONTHS TO HEAL DESPITE OTHERWISE GOOD HEALING. HE ALSO SUFFERED SEVERE PERMANENT ULNAR NEUROPATHY WITH COMPLETE NUMBNESS AND ALMOST COMPLETE PARALYSIS OF BILATERAL ULNAR DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79439 SST (500 LBS) W/GIMBALS & SHEARGUARD GE PADS W/MODULAR CART TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO OSI 5943 5943

    Patients

    Seq Age Sex Outcome Treatment
    1 Other