BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAGEN 3MM X 2CM 1 UNIT

    MDR report key: 1100207 · Received July 31, 2008

    Report

    Report Number
    1121308-2008-00011
    Event Type
    Other
    Date Received
    July 31, 2008
    Date of Event
    November 12, 2007
    Report Date
    July 31, 2008
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR RETURN FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE WAS IMPLANTED IN 2007 DURING A LEFT RADIAL EXTREMITY EXPLORATION AND REPAIR. THE DEVICE THAT WAS IMPLANTED HAD AN EXPIRATION DATE OF MAY 31, 2007. THE DEVICE WAS NOT REMOVED. THE REPORTER HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL CLINICAL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAGEN 3MM X 2CM 1 UNIT NEURAGEN NERVE GUIDE JXI INTEGRA LIFESCIENCES 1051325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other