BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN PAL STIRRUP

    MDR report key: 6066188 · Received October 31, 2016

    Report

    Report Number
    6066188
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING POSITIONED FOR SURGERY ON OR TABLE. WHEN PLACING THE PATIENT'S LEGS IN ALLEN PAL STIRRUPS, THE RIGHT STIRRUP DETACHED FROM THE OPERATING ROOM TABLE CAUSING THE PATIENT'S RIGHT LEG TO FALL. THE TWO DOCTORS PRESENT EVALUATED THE PATIENT'S LEG FOR VISIBLE INJURY, NONE NOTED. A POST-OP X-RAY OF RIGHT HIP WAS ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719121 ALLEN PAL STIRRUP ACCESSORIES, OPERATING-ROOM, TABLE FWZ ALLEN MEDICAL SYSTEMS, INC. A-264498

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR