BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE DURA SUBSTITUTE

    MDR report key: 3199263 · Received June 25, 2013

    Report

    Report Number
    2017233-2013-00402
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    October 1, 2004
    Report Date
    June 7, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GXQ
    PMA / PMN Number
    K953969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER IS UNAVAILABLE, A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. LITERATURE CITATION: YOSHIOKA N, ET.AL. TREATMENT FOR POSTCRANIOTOMY INFECTION WHEN USING EPTFE SHEET AS AN ARTIFICIAL DURA MATER. JAPANESE JOURNAL OF NEUROSURGERY 2007; 16:555-560.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "TREATMENT FOR POSTCRANIOTOMY INFECTION WHEN USING EPTFE SHEET WAS AN ARTIFICIAL DURA MATER" PUBLISHED IN JAPANESE JOURNAL OF NEUROSURGERY, 2007. THE ARTICLE REPORTS A PATIENT UNDERWENT A CRANIOTOMY FOR AN ARTERIOVENOUS MALFORMATION. AN EPTFE SHEET WAS USED FOR ARTIFICIAL DURA MATER IN THE PROCEDURE. A POSTOPERATIVE INFECTION AND REFRACTORY SKIN FISTULA DEVELOPED, FOLLOWING WHICH, THE EPTFE SHEET WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287613 GORE PRECLUDE DURA SUBSTITUTE GXQ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other