BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3051657 · Received April 10, 2013

    Report

    Report Number
    1531186-2013-01504
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    LERADO GLOBAL
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER UNIT WILL NOT TIGHTEN DOWN TO THE BOWL. ALSO STATES A PART FELL OFF OF THE PRODUCT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148129 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS LERADO GLOBAL 1302RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other