BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I

    MDR report key: 5358328 · Received January 11, 2016

    Report

    Report Number
    3006697299-2016-00008
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Report Date
    January 6, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETROSPECTIVE REVIEW OF COMPLAINT INDICATES CORRECTION MDR IS NEEDED. INITIAL MDR FILED WITH INCORRECT ESTABLISHMENT REGISTRATION NUMBER (8010219-2015-00007).

    Description of Event or Problem · 1

    RETROSPECTIVE REVIEW OF COMPLAINT INDICATES CORRECTION MDR IS NEEDED. INITIAL MDR FILED WITH INCORRECT ESTABLISHMENT REGISTRATION NUMBER (8010219-2015-00007).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16526 MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I N/A GWM INTEGRA NEUROSCIENCES, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1