BEUDAMED
    FDA Adverse Event Other Summary report: N

    YELLOFIN ELITE STIRRUP

    MDR report key: 2655746 · Received July 3, 2012

    Report

    Report Number
    1221538-2012-00003
    Event Type
    Other
    Date Received
    July 3, 2012
    Date of Event
    June 11, 2009
    Report Date
    June 5, 2012
    Manufacturer
    ALLEN MEDICAL
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFICIENCIES OR MALFUNCTIONS WERE REPORTED WITH THE ALLEN STIRRUP, WHICH WAS NOT TAKEN OUT OF USE FOLLOWING THE 2009 PROCEDURE. THE INJURY, WHICH COULD NOT BE ATTRIBUTED DIRECTLY TO THE STIRRUP, WAS NOT REPORTED TO US. THERE HAS BEEN NO RETURN OF THE STIRRUP FOR EVALUATION AND THE SERIAL NUMBER - NEEDED FOR IDENTIFICATION AND AGING PURPOSES, WAS NOT PROVIDED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(4) 2012, AN ATTORNEY REPRESENTING OB/GYN (B)(6) OF (B)(6), CONTACTED ALLEN MEDICAL TO REQUEST POSITIONING INFO FOR OUR STIRRUPS. DURING THIS CONTACT, A PREVIOUSLY UNREPORTED POSITIONING INJURY FROM 2009 CASE WAS REPORTED. ACCORDING TO THE ATTORNEY, IT WAS AT THE END OF AN ABDOMINAL HYSTERECTOMY CASE, AS THE PT WAS BEING REMOVED FROM THE OPERATING TABLE (DORSAL / SUPINE POSITION), SOME "FRESH BLEEDING" WAS NOTED AND THE SURGEON ASKED THE STAFF TO PLACE THE STILL ANESTHETIZED PT INTO A PAIR OF YELLOFIN STIRRUPS FOR EXAMINATION. THE STIRRUPS WERE ONLY USED FOR 15 - 18 MINUTES AND NO INCIDENT OCCURRED, THE ATTORNEY SAID. POST-OPERATIVELY IN RECOVERY, THE PT REPORTED NUMBNESS AND WEAKNESS IN HER LEFT LEG, THE ATTORNEY SAID. AT SOME POINT LATER, THIS WORSENED AND DAMAGE TO THE PERONEAL NERVE (LEFT SIDE) WAS DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YELLOFIN ELITE STIRRUP YELLOFIN ELITE BWN ALLEN MEDICAL O-YFES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability