BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3910877 · Received July 2, 2014

    Report

    Report Number
    1531186-2014-02337
    Date Received
    July 2, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    LERADO
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE CLAMP WHICH SECURES THE SEAT TO THE TOILET BROKE OFF AND THE END USER FELL TO THE FLOOR AS A RESULT, INCIDENT TOOK PLACE ON (B)(6) 2014. DEALER STATES THE END USER WAS NOT INJURED. DEALER VISITED THE END USER AND STATED ALSO THE END USER WAS WALKING AND HE WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386430 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS LERADO 1302RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other