BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURAGEN STRIP 8 CTS

    MDR report key: 1915304 · Received November 2, 2010

    Report

    Report Number
    9612007-2010-00034
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURAGEN STRIP 8 CTS AURAGEN STRIP ELECTRODE GYC INTEGRA NEUROSCIENCES IMPLANTS S.A. 159502

    Patients

    Seq Age Sex Outcome Treatment
    1