BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFINS STIRRUPS WITHOUT LIFT ASSIST

    MDR report key: 3189852 · Received June 12, 2013

    Report

    Report Number
    3189852
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    December 17, 2012
    Report Date
    March 5, 2013
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN PROBLEMS WITH STAFF OVER TIGHTENING THE BRACKET WHICH WEARS THE "TEETH" DOWN SO IT WILL NOT HOLD UP AS WELL AS IT SHOULD. A POSSIBLE DESIGN FLAW WITH YELLOFIN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267833 YELLOFINS STIRRUPS WITHOUT LIFT ASSIST STIRRUPS EYD ALLEN MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *