BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFIN STIRRUPS WITHOUT LIFT ASSIST

    MDR report key: 3307820 · Received July 31, 2013

    Report

    Report Number
    1221538-2013-00011
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    December 17, 2012
    Report Date
    July 1, 2013
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALLEN MEDICAL SYSTEMS RECEIVED A MEDWATCH REPORT ((B)(4)) FROM FDA WHICH HAD BEEN SUBMITTED IN REGARD TO AN ISSUE REPORTED TO OCCUR AT (B)(6). THE FOLLOWING ISSUE WAS REPORTED IN REGARD TO THE ALLEN YELLOFIN STIRRUP: "EVENT DESC: THERE HAVE BEEN PROBLEMS WITH STAFF OVER TIGHTENING THE BRACKET WHICH WEARS THE "TEETH" DOWN SO IT WILL NOT HOLD UP WELL AS IT SHOULD. A POSSIBLE DESIGN FLAW WITH YELLOFIN. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". NO SERIAL NUMBER WAS PROVIDED. THE DEVICE WAS NOT MADE AVAILABLE TO ALLEN MEDICAL FOR EVAL. NO PT INVOLVEMENT WAS REPORTED. NO COMPLAINT WAS MADE TO ALLEN MEDICAL SYSTEMS BY THE REPORTER, (B)(6). THE YELLOFIN STIRRUP DOES NOT HAVE TEETH NOR A BRACKET WHICH IS TIGHTENED DURING SETUP OR USE. NO OTHER CUSTOMER COMPLAINTS HAVE BEEN REPORTED TO ALLEN MEDICAL REGARDING THIS PROBLEM. PHONE CONTACT WAS MADE WITH (B)(6) ON (B)(6) 2013 AND SHE WAS NOT ABLE TO CLARIFY THE NATURE OF THE REPORTED EVENT/ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358504 YELLOFIN STIRRUPS WITHOUT LIFT ASSIST STIRRUPS EYD ALLEN MEDICAL SYSTEMS, INC. O-YFSI

    Patients

    Seq Age Sex Outcome Treatment
    1