BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFINS ELITE STIRRUPS WITH LIFT-ASSIST

    MDR report key: 5528570 · Received March 28, 2016

    Report

    Report Number
    5528570
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 25, 2016
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    YELLOW FIN STIRRUP USED ON PATIENT'S LEFT LEG DID NOT HOLD ITS POSITION DURING SURGERY AND PATIENT'S LEG WAS IN STRAIGHT POSITION AT END OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185390 YELLOFINS ELITE STIRRUPS WITH LIFT-ASSIST ACCESSORIES, OPERATING-ROOM, TABLE FWZ ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR OTHER, GENERAL ANESTHESIA