BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3203055 · Received July 2, 2013

    Report

    Report Number
    1531186-2013-02926
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE 6895 SHOWER COMMODE COLLAPSE WHILE IN USE. AS A RESULT, THE PATIENT FELL, HITTING HIS HEAD AND SUSTAINING CUTS AND BRUISES. THE PATIENT FURTHER ADVISED THE SHOWER COMMODE BEGAN TO BOW IN (B)(6) 2013 AND PROGRESSIVELY WORSENED THROUGH TIME. NO INFORMATION REGARDING THE SEVERITY OR TREATMENT OF THE PATIENT'S INJURIES WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301114 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 28 Other| R