BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 5511111 · Received March 18, 2016

    Report

    Report Number
    3007082252-2016-00004
    Event Type
    Death
    Date Received
    March 18, 2016
    Date of Event
    February 26, 2013
    Report Date
    March 16, 2016
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS DENIED THAT THE SYSTEM 83 PLUS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AS ALLEGED IN THE LEGAL DOCUMENTS.

    Additional Manufacturer Narrative · 1

    THE CORRECT DATE OF EVENT IS "UNKNOWN".

    Additional Manufacturer Narrative · 1

    THIS MATTER AND ANY INVESTIGATION RELATED TO THE SAME IS OFFICIALLY CLOSED. THE COMPLAINT ONLY AROSE SOLELY OUT OF ALLEGATIONS IN LAWSUIT AND THIS LAWSUIT HAS BEEN RESOLVED WITH ABSOLUTELY NO FINDING OF LIABILITY OR WRONGDOING ON BEHALF OF CUSTOM ULTRASONICS, INC.

    Description of Event or Problem · 1

    ADVERSE EVENT AS ALLEGED SOLELY IN LEGAL DOCUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166568 SYSTEM 83 PLUS ENDOSCOPE WASHER DISINFECTOR FEB CUSTOM ULTRASONICS INC. UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death