BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKMOVE

    MDR report key: 7799031 · Received August 20, 2018

    Report

    Report Number
    3009481053-2018-00033
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FDA ESG WEBTRADER ACCOUNT WAS DISABLED, A NEW ACCOUNT WAS SET UP TO SUBMIT MDR'S AND SO THE DELAY IN SUBMISSION.

    Description of Event or Problem · 1

    LEG STUD BROKE AT GROOVE/UNDERCUT, SEPARATING LEG FROM FRAME TUBE. THREADED ROD BALL JOINT CLIPS MISSING. EVENT OCCURRED DURING PATIENT TRANSFER. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639822 QUICKMOVE FLOOR LIFT IKX HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1