BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFIN ELITE

    MDR report key: 3590695 · Received January 15, 2014

    Report

    Report Number
    3590695
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 15, 2014
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S LEGS WERE BEING POSITIONED AND AS THE SURGICAL TECHNICIAN ADJUSTED THE YELLOFIN STIRRUP, IT BROKE. THERE WAS NO PATIENT INJURY. THE PATIENT WEIGHED 110 POUNDS AND HER LEG WAS CAUGHT BEFORE IT HIT THE OPERATING FLOOR. THIS HAS OCCURRED ON 3 SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39916 YELLOFIN ELITE STIRRUPS EYD ALLEN MEDICAL SYSTEMS, INC. * *
    39917 YELLOFIN ELITE STIRRUPS EYD ALLEN MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *