BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 534774 · Received July 19, 2004

    Report

    Report Number
    9617021-2004-00084
    Event Type
    Malfunction
    Date Received
    July 19, 2004
    Date of Event
    June 27, 2004
    Report Date
    July 13, 2004
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE PT HAD BEEN LIFTED IN A LARGE SLING AND WAS IN A SLIGHT SITTING POSITION. DURING TRANSFER TO THE BATHROOM (BACKWARDS), THE PT SUDDENLY HUNG UPSIDE DOWN WITH THEIR LEGS STILL IN THE SLING. THE PT'S HEAD TOUCHED THE MAST, WHICH CAUSED A BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA PPP PATIENT LIFT FSA ARJO MED AB LTD. KPBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN