BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3000733 · Received March 12, 2013

    Report

    Report Number
    1531186-2013-01048
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    LERADO GLOBAL
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE ARMS OF THE TOILET SEAT ARE WOBBLY AND ONE ARM GAVE OUT WHICH COULD CAUSE THE USER TO HAVE INSTABILITY WHEN GETTING UP FROM THE SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103013 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS LERADO GLOBAL 1302RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other