BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1359116 · Received April 7, 2009

    Report

    Report Number
    1221538-2009-00003
    Event Type
    Injury
    Date Received
    April 7, 2009
    Date of Event
    May 8, 2008
    Report Date
    April 7, 2009
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    EYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. CO HAS NOT RECEIVED PHOTOGRAPHS OF THE DEVICE WHICH MAY HELP US UNDERSTAND THE NATURE OF THE COMPLAINT. IN LEGAL DOCUMENTS, THE SERIAL NUMBER PROVIDED FOR THE PRODUCT WAS REPORTED INCORRECTLY. (THE DEVICE IS ASSOCIATED WITH A RAIL CLAMP PRODUCT AND NOT A STIRRUP.) DUE TO THE LACK OF INFO, NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IN 2009, ALLEN MEDICAL LEARNED OF A LAWSUIT FILED REGARDING A PREVIOUSLY UNREPORTED 2008 INCIDENT INVOLVING A NURSE FROM MEDICAL CENTER. THERE WAS NO PT INVOLVEMENT. ACCORDING TO THE LEGAL COMPLAINT, THE NURSE "LIFTED UPON THE STIRRUP TO REMOVE IT FROM THE OPERATING TABLE. AS SHE LIFTED THE STIRRUP OUT OF THE SLOT ON THE OPERATING TABLE, THE STIRRUP UNEXPECTEDLY AND WITHOUT WARNING ENGAGED CAUSING THE STIRRUP TO SNAP SHUT ON PLAINTIFF'S LEFT HAND." ACCORDING TO THE DOCUMENT, "SEVERE AND PERMANENT INJURIES" WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS YELLOFIN STIRRUP EYD ALLEN MEDICAL SYSTEMS O-YFASI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Disability