BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH

    MDR report key: 4355941 · Received December 17, 2014

    Report

    Report Number
    3003418325-2014-00011
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Report Date
    November 20, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT IS REPORTED; THE DISTRIBUTOR RECEIVED A PHONE CALL FROM THE CUSTOMER REGARDING THE USE OF THE NEURAGEN DEVICE THAT WAS IMPLANTED IN (B)(6) 2014. THE EXPIRATION DATE WAS (LATER) NOTED TO BE (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829996 NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORPORATION 1125173

    Patients

    Seq Age Sex Outcome Treatment
    1