BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4222700 · Received November 4, 2014

    Report

    Report Number
    1219590-2014-00185
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 30, 2014
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT ONE OF THE LEGS ON THEIR 50-1 SHOWER CHAIR BROKE WHERE THEY CROSS UNDER THE SEAT WHILE SITTING, USER FELL BACKWARDS, HIT HER HEAD ON THE DOOR AND SUSTAINED BRUISES ON THE ARMS. CUSTOMER LIVES ALONE AND IT TOOK HER ABOUT 20 MINUTES TO GET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706375 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVACARE CLEVELAND STREET 50-1

    Patients

    Seq Age Sex Outcome Treatment
    1 83 Other