BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN YELLOFIN STIRRUPS

    MDR report key: 10453542 · Received August 26, 2020

    Report

    Report Number
    10453542
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    June 10, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF ATTEMPTED TO POSITION THE LEG OF THE PATIENT WHILE PLACED IN THE ALLEN YELLOFIN STIRRUP. THE STIRRUP CAME FREE FROM THE CLAMP ATTACHED TO THE BED. STAFF HAD TO HOLD OF THE LEG OF THE PATIENT AND DONG SO WITHOUT PUTTING STRESS ON THE PATIENT'S EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920641 ALLEN YELLOFIN STIRRUPS OPERATING ROOM ACCESSORIES TABLE TRAY FWZ ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA