BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3244944 · Received December 17, 2012

    Report

    Report Number
    2921578-2012-00024
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER IS COMPLAINING THAT WHEN THEY USE THE 5943 MIZUHO OSI SPINAL SURGICAL TABLE, PTS ARE EXPERIENCING SKIN ULCERS ON THEIR CHEST AFTER SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other