BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA PLUS

    MDR report key: 3226023 · Received July 5, 2013

    Report

    Report Number
    1419652-2013-00175
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FRW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE COMPANY REPRESENTATIVE DESCRIPTION: 'THE PATIENT WAS BEING LIFTED INTO A STANDING POSITION USING THE SARA PLUS. ONCE IN THE STANDING POSITION THE PATIENT BECAME UNSTEADY. HE TRIED TO STEP OFF OF THE FOOT BOARD AND THEN COLLAPSED. IN AN ATTEMPT TO RELEASE HIM FROM THE SLING THE STAFF LET LOOSE THE SLING CORDS. HE THEN SLUMPED DOWN CATCHING HIS THROAT AGAINST ONE OF THE SLING CORDS. HE STARTED TO ASPHYXIATE AND THE CRASH TEAM WAS CALLED'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307612 SARA PLUS NONE FRW ARJOHUNTLEIGH POLSKA SP. ZO.O. HEP2001-UK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization