BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1695573 · Received May 18, 2010

    Report

    Report Number
    1695573
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    March 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS PRONE ON THE JACKSON SPINE TABLE WITH SLING. AT THE END OF THE PROCEDURE THERE WERE REDDENED AREAS WITH ABRASIONS NOTED IN BILATERAL GROIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SYSTEM, SUPPORT, PAD JEA MIZUHO OSI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR
    2 54 YR