BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER PRESENCE

    MDR report key: 7821816 · Received August 28, 2018

    Report

    Report Number
    3010605276-2018-00004
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 28, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED THE MDR EVENT FROM OUR USA DISTRIBUTOR AND COMPLAINT#(B)(4) WAS ENTERED INTO OUR SYSTEM. THE MDR EVENT ON THIS REPORT FROM OUR USA DISTRIBUTOR IS STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, " HE STATES THAT HIS DAUGHTER'S FEET KEEP HITTING THE LIFT DURING TRANSFERS AND IS INJURING HER FEET." THE PATIENT HAS SUSTAINED BRUISES ON THE FEET. THE LIFT INVOLVED REMAINS IN-SERVICE. TRAINING WAS OFFERED TO THE FACILITY AND THEY DECLINED. COMPLAINT#(B)(4) WAS ENTERED INTO JOERNS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664355 HOYER PRESENCE ELECTRIC PATIENT LIFT, PRODUCT CODE: FSA FSA APEX HEALTH CARE MFG., INC. HOY-PRESENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other