BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFINS STIRRUPS

    MDR report key: 1567405 · Received December 28, 2009

    Report

    Report Number
    MW5014125
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 28, 2009
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF OUTPATIENT SURGICAL PROCEDURE, PT'S LEGS WERE PLACED IN YELLOFINS STIRRUPS. PT HAD BEEN GIVEN LOCAL MAC AND WAS MOVING ABOUT THE TABLE WHEN THE HYDRAULICS ON THE LEFT STIRRUP RELEASED AND LOWERED PT'S LEFT LEG WITH THE STIRRUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YELLOFINS STIRRUPS HYDRAULIC STIRRUPS EYD ALLEN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR STIRRUPS BEING USED WITH AMSCO SURGICAL TABLE