BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3133033 · Received May 29, 2013

    Report

    Report Number
    1531186-2013-02329
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THE CONSUMER ADVISED WHEN SEATED THE LEFT SIDE OF THE LEGS GIVE MORE THAN THE RIGHT SIDE CAUSING HER TO BE UNEVEN AND WOBBLY ON THE SEAT. THE DEALER STATES THE CONSUMER IS UNDER THE WEIGHT CAPACITY OF THE PRODUCT OF 315 LBS. HE STATES SHE WEIGHS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237237 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 91-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other