BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 1240884 · Received November 10, 2008

    Report

    Report Number
    2182305-2008-00042
    Event Type
    Other
    Date Received
    November 10, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 16, 2008
    Manufacturer
    APEX HEALTHCARE MFG INC
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR, BY FACILITY; PER FACILITY, THEY HAVE STOPPED USING THIS LIFT BECAUSE TWO OF THEIR SENIOR RESIDENTS RECEIVED HEMOTOMAS UNDER THEIR ARMPITS FROM THE SLING THAT IS REQUIRED FOR THE LIFT. ALL OF THEIR PTS, INCLUDING THE NURSES THAT EXPERIENCED GETTING LIFTED FROM THIS LIFT COMPLAINED OF UNCOMFORTABLE PRESSURE UNDER THE ARMS. PER FACILITY, THEY HAVE HAD PROBLEMS WITH THE SLINGS FROM THE BEGINNING; "THE SLINGS RIDE UP ON THEIR RESIDENTS EVEN WHEN ATTACHED CORRECTLY." PER MFR THIS IS A FIRST TIME COMPLAINT OF THIS KIND FROM CUSTOMERS WHEN USING THE ASCEND AID LIFT. ASKING FOR PICTURES TO EVALUATE IF FACILITY IS USING THE CORRECT COMBINATION OF SLING T LIFT, AND THE CORRECT SIZE OF SLING FOR THEIR RESIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FNG APEX HEALTHCARE MFG INC ASCEND STAND AID

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other