BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAGEN NERVE GUIDE 3MM ID X 3CM LENGTH

    MDR report key: 3919522 · Received June 11, 2014

    Report

    Report Number
    1121308-2014-00019
    Event Type
    Other
    Date Received
    June 11, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    JXI
    PMA / PMN Number
    K011168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT A HAND SURGEON IMPLANTED EXPIRED NEURAGEN IN A PT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344104 NEURAGEN NERVE GUIDE 3MM ID X 3CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORP. 1121506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other