BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOLVO

    MDR report key: 834636 · Received April 2, 2007

    Report

    Report Number
    1225750-2007-00007
    Event Type
    Other
    Date Received
    April 2, 2007
    Date of Event
    March 10, 2007
    Report Date
    March 21, 2007
    Manufacturer
    LIKO INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 15, 2007, A LIKO DISTRIBUTOR WAS ALLOWED TO VIEW AND EXAMINE THE GOLVO PATIENT LIFT USED IN THE REPORTED INCIDENT. THE LIFT HAD NOT BEEN REMOVED FROM SERVICE AND WAS FOUND TO BE IN GOOD WORKING ORDER. THE SLING USED IN THE TRANSFER WAS NOT A LIKO MANUFACTURED SLING, AND THEREFORE WAS NOT DESIGNED, TESTED OR APPROVED FOR USE WITH A LIKO PATIENT LIFT. LIKO INC. STRONGLY DISCOURAGES THE USE OF NON-APPROVED SLINGS AND ACCESSORIES WITH THEIR EQUIPMENT. REMEDIAL TRAINING ON THE PROPER USE OF THIS EQUIPMENT WAS OFFERED TO THE FACILITY.

    Description of Event or Problem · 1

    FACILITY REPORTS THAT WHILE TRANSFERRING A RESIDENT USING A GOLVO 7007ES PATIENT LIFT, THE SLING CAME OFF THE HANGER BAR AND RESIDENT FELL AND BROKE HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLVO * FSA LIKO INC. GOLVO 7007 ES *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other