BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 5545462 · Received April 4, 2016

    Report

    Report Number
    3007082252-2016-00011
    Date Received
    April 4, 2016
    Report Date
    April 1, 2016
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LEGAL DOCUMENTS.

    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

    AS ALLEGED IN LEGAL DOCUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200289 SYSTEM 83 PLUS ENDOSCOPE WASHER DISINFECTOR FEB CUSTOM ULTRASONICS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1