BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2180545 · Received July 27, 2011

    Report

    Report Number
    1525712-2011-00384
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER SAT ON THE EDGE OF THE TRANSFER BENCH AND MOVED TO THE OPPOSITE SIDE OVER THE TUB, WHEN THE FRONT LEGS ALLEGEDLY SPREAD FORWARDS, CAUSING THE FRONT TUBING UNDER THE MIDDLE SEAT PAD TO CRACK. THE CONSUMERS HUSBAND ALLEGEDLY PREVENTED HER FROM FALLING. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 9871

    Patients

    Seq Age Sex Outcome Treatment
    1 45