BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE

    MDR report key: 2103265 · Received May 17, 2011

    Report

    Report Number
    1121308-2011-00013
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    A PT EXPERIENCED A (CSF) CEREBROSPINAL FLUID LEAK AFTER USING A 4X5 PIECE OF SUTURABLE DURAGEN (DURS4591) DURING A CRANIOTOMY. THE IMPLANT WAS DONE ON (B)(6) 2010. THE REVISION TOOK PLACE ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1