BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4121867 · Received September 26, 2014

    Report

    Report Number
    1531186-2014-04481
    Date Received
    September 26, 2014
    Report Date
    September 8, 2014
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT TWO OF THE LEGS ON A 96-2 SHOWER CHAIR HAVE BENT OUTWARD, THE SEAT ALSO TWISTED CAUSING THE USER TO FALL. USER IS SORE BUT NO MEDICAL INTERVENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600904 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 96-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other