BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAGEN NERVE GUIDE 2MM ID X 2CM LENGTH

    MDR report key: 1728843 · Received June 14, 2010

    Report

    Report Number
    1121308-2010-00014
    Event Type
    Other
    Date Received
    June 14, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 14, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON IMPLANTED, INTO ONE PATIENT, THREE NEURAGEN PRODUCTS FROM THE HOSPITAL INVENTORY THAT HAD EXCEEDED THEIR LABEL EXPIRATION DATES: PNG220 LOT 1070331 EXPIRATION DATE MARCH 2009 (NEURAGEN NERVE GUIDE 2MM ID X 2 CM LENGTH), PNG420 LOT 1080280 EXPIRATION DATE JANUARY 2010 (NEURAGEN NERVE GUIDE 4MM ID X 2 CM LENGTH), PNG420 LOT 1073029 EXPIRATION DATE OCTOBER 2009 (NEURAGEN NERVE GUIDE 4MM ID X 2 CM LENGTH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAGEN NERVE GUIDE 2MM ID X 2CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORP. 1070331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other