BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCARE LIFT

    MDR report key: 11962715 · Received June 8, 2021

    Report

    Report Number
    3007802293-2021-00006
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Report Date
    June 8, 2021
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING ON THIS UNIT TO BE RETURNED SO AN INVESTIGATION CAN BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    STAFF USED LIFT TO PUT RESIDENT ON TOILET. WHEN THEY WERE GOING TO LIFT RESIDENT OFF TOILET, THEY NOTICIED LIFT GIVE WAY, AND DID NOT LIFT RESIDENT. THE RESIDENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857879 MEDCARE LIFT MOBILE LIFT FSA HANDICARE USA INC. 400013

    Patients

    Seq Age Sex Outcome Treatment
    1