BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA PPP

    MDR report key: 476495 · Received August 5, 2003

    Report

    Report Number
    9617021-2003-00050
    Event Type
    Malfunction
    Date Received
    August 5, 2003
    Date of Event
    May 13, 2003
    Report Date
    August 1, 2003
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHEN TRANSFERRING THE RESIDENT FROM THE CHAIR TO THE BED, THE LEFT CLIP ON THE SLING CAME UNHOOKED. THE RESIDENT FELL AND SUFFERED A BRUISE TO THE HEAD AND LEFT SHOULDER.

    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 97 YR