BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO

    MDR report key: 1952243 · Received January 4, 2011

    Report

    Report Number
    8030916-2010-00082
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    September 8, 2010
    Report Date
    December 6, 2010
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION WAS PERFORMED BY LOCAL DISTRIBUTOR AND FACILITY STAFF. FACILITY USED A NON LIKO MANUFACTURED SLING ON A LIKO LIFT. ADMINISTRATOR ALLEGED USER ERROR AS WRONG STYLE AND BRAND SLING WAS USED. NO ALLEGED MALFUNCTION OF THE LIFT.

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT THEY MISTAKENLY USED A NON LIKO MANUFACTURED SLING WHEN TRANSFERRING A RESIDENT ON A LIKO MOBILE LIFT. THE PT SLID OUT OF THE SLING AND HIT HER HEAD ON THE FLOOR. PT RECOVERED. ADMINISTRATOR ALLEGED USER ERROR IN USING NON LIKO BRAND SLING MAY HAVE CAUSED THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO NON-AC POWERED PT LIFT FSA LIKO AB UNO 102EE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other