BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH

    MDR report key: 2111052 · Received May 17, 2011

    Report

    Report Number
    1121308-2011-00014
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    February 11, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT NEURAGEN WAS IMPLANTED INTO A PT DURING A SURGICAL PROCEDURE AFTER THE LABEL EXPIRATION DATE. LOT 1090372 EXPIRES JAN 31, 2011 AND THE CASE WAS (B)(4), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH NEURAGEN JXI INTEGRA, PLAINSBORO 1090372

    Patients

    Seq Age Sex Outcome Treatment
    1