BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE

    MDR report key: 2297729 · Received October 10, 2011

    Report

    Report Number
    1121308-2011-00035
    Event Type
    Death
    Date Received
    October 10, 2011
    Report Date
    October 10, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    A PATIENT UNDERWENT A CRANIOTOMY FOR A BRAIN TUMOR ON (B)(6), 2011 AND DURAGEN SUTURABLE 4X5 (DURS-4591) WAS IMPLANTED DURING THE PROCEDURE. ACCORDING TO THE INITIAL REPORT RECEIVED FROM THE INTEGRA LIFESCIENCES REPRESENTATIVE, THE PATIENT WAS SUSPECTED TO HAVE A HIGH LIKELIHOOD OF (B)(6) BUT NOT A 100% CONFIRMED DIAGNOSIS WAS MADE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE INFECTION CONTROL NURSE WHO "INDICATED THE PATIENT HAD TWO FALSE POSITIVE CULTURES FOR (B)(6)." A THIRD CULTURE WAS DONE, BUT THE RESULTS ARE PENDING. THE NURSE REPORTED "THAT IT IS HIGHLY UNLIKELY THE PATIENT HAD (B)(6)." THE PATIENT DIED ON (B)(6) 2011. AN AUTOPSY WILL CONFIRM THE DIAGNOSIS. THE AUTOPSY REPORT HAS BEEN REQUESTED BUT, THE RESULTS ARE NOT EXPECTED FOR SEVERAL WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE N/A GXQ INTEGRA, PLAINSBORO 1104412

    Patients

    Seq Age Sex Outcome Treatment
    1 Death