BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA PLUS

    MDR report key: 3081488 · Received April 4, 2013

    Report

    Report Number
    1419652-2013-00071
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z.O.O.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE ARJOHUNTLEIGH REP: "TRANSFER FROM WHEELCHAIR TO TOILET, THE LIFT LEGS WERE IN SPREAD POSITION AND REFUSED TO CLOSE. AT THIS MOMENT, THE ARM WENT UP BY ITSELF, CLIENT GOT PANIC BECAUSE THE ARM REST GOT HIGH AND MADE THE ARMS END UP IN A STRANGE POSITION SO SHE LET THE ARMREST GO. FALL THROUGH HER LEGS AND GOT STUCK BETWEEN AT THE LEG SUPPORT. HIGH PRESSURE BECAME ON HER LEGS AND ANKLES BECAUSE SHE COULD NOT REPLACE HER LEGS AND ALL THE WEIGHT AND PRESSURE CAME ON IT. EQUIPMENT SERVICE IS DONE BY 3RD PARTY." REFERENCE TO MFR REPORT NUMBER 3007420694-2013-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139692 SARA PLUS ACTIVE FLOOR LIFTS FNG ARJOHUNTLEIGH POLSKA SP. Z.O.O. HEP0001

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization