BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE LIFTS AND SLINGS

    MDR report key: 1080420 · Received July 16, 2008

    Report

    Report Number
    1525712-2008-00066
    Event Type
    Injury
    Date Received
    July 16, 2008
    Date of Event
    April 1, 2008
    Report Date
    July 14, 2008
    Manufacturer
    INVACARE CORP.-MANUFACTURING FACILITY
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN IN USE FOR 8 YEARS AND IS NO LONGER IN WARRANTY, INFO INDICATES A POTENTIAL TRANSFER ERROR. UNCLEAR IF PROPER MAINTENANCE HAS BEEN PERFORMED ON THE LIFT PRIOR TO ALLEGED INCIDENT. MDR FILED BASED ON SERIOUS INJURY CLAIM.

    Description of Event or Problem · 1

    THE MANUAL BASE WIDENING MECHANISM ALLEGEDLY CLOSED THE LEGS DURING THE TRANSFER, CAUSING THE LIFT TO TURN ON ITS SIDE AND THE CONSUMER TO FALL ONTO THE TILE FLOOR. THE CONSUMER ALLEGEDLY SUSTAINED A HIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE LIFTS AND SLINGS 880.5510 FSA INVACARE CORP.-MANUFACTURING FACILITY RPL450-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention