BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3011675 · Received March 19, 2013

    Report

    Report Number
    1525712-2013-02078
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE UNSPECIFIED MODEL SHOWER CHAIR ALLEGEDLY BROKE DURING USE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113158 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other