BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4211178 · Received October 29, 2014

    Report

    Report Number
    1531186-2014-05161
    Date Received
    October 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE HEIGHT ADJUSTMENT SNAP BUTTONS ON A 1392KD TOILET SAFETY FRAME POPPED OUT FROM THE FRAME. THE LEG FELL DOWN CAUSING END USER TO FALL. USER REPORTED THAT SHE DID NOT HURT HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691460 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 1392KD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other