BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE

    MDR report key: 441730 · Received February 5, 2003

    Report

    Report Number
    441730
    Event Type
    Other
    Date Received
    February 5, 2003
    Date of Event
    April 1, 2002
    Report Date
    August 1, 2002
    Manufacturer
    ARJO INC.
    Product Code
    FSA
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY STARTED USING A NEW MECHANICAL LIFT CALLED THE ENCORE TO ASSIST PTS WITH STANDING AND TRANSFERRING. THE LIFT INVOLVES PARTIAL WEIGHT-BEARING BY THE PT WHO STANDS AGAINST THE DEVICE AND HOLDS ONTO GRIP HANDLES DURING THE TRANSFER. IT WAS NOTED THAT THE PT INVOLVED DEVELOPED BRUISES ON BOTH SHINS FROM THE PLASTIC PADS THAT REST AGAINST THE FRONT OF THE LEG BETWEEN THE KNEE AND THE ANKLE. THE SITE CONTACTED THE MFR ABOUT THIS PROBLEM WHO RECOMMENDED THAT THE FACILITY PURCHASE SHEEPSKIN PADS THAT THEY SUPPLY. THERE WAS NO MENTION BY THE MFR THAT THE SHEEPSKIN PADDING WAS AVAILABLE DURING THE TIME THAT STAFF TRAINING OCCURRED ON THE DEVICE. THE SHEEPSKIN PADS WERE PURCHASED BY THE LONG TERM CARE FACILITY. PT BRUISING SUBSIDED WITH THE USE OF THE PADS. IT IS BELIEVED THE WEIGHT BEARING STATUS AND PHYSICAL ABILITY OF THE PT DOES NOT IMPACT ON THE DEGREE OF INJURY. THE DEVICE IS BEING USED IN THE LONG TERM CARE FACILITY WHERE THE STAFF HAVE BEEN INSERVICED ON THE USE OF THIS DEVICE BY THE COMPANY'S REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE PATIENT LIFT FSA ARJO INC. KKA5020 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other