BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ WAY STAND

    MDR report key: 929176 · Received October 17, 2007

    Report

    Report Number
    2183887-2007-00002
    Event Type
    Injury
    Date Received
    October 17, 2007
    Date of Event
    September 16, 2007
    Report Date
    October 16, 2007
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A RESIDENT WAS BEING TRANSFERRED WITH A STAND FROM A TOILET TO A WHEELCHAIR WHEN THE RESIDENT STARTED TO SLIP OUT OF THE HARNESS USED WITH THE STAND. THE CAREGIVER HELPED LOWER THE RESIDENT TO THE GROUND. THE RESIDENT BROKE HER FEMUR WHILE BEING LOWERED. AN EZ WAY REPRESENTATIVE INVESTIGATED THE INCIDENT AND FOUND THE FACILITY WAS USING A HARNESS MANUFACTURED BY ANOTHER COMPANY, AND WAS NOT DESIGNED OR CERTIFIED FOR USE WITH THE EZ WAY STAND. SHE THEN REPLICATED THE SCENARIO USING THE HARNESS NOT MANUFACTURED BY EZ WAY, AND WAS ABLE TO REPLICATE THE SLIPPING. THEY THEN REPLICATED THE SCENARIO USING THE EZ WAY HARNESS, AND WERE NOT ABLE TO SLIP OUT OF THE HARNESS. THE STAFF WAS INSTRUCTED TO ONLY USE EZ WAY ACCESSORIES WITH EZ WAY EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ WAY STAND PATIENT LIFT FNG EZ WAY, INC. 898 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other