BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE DURA SUBSTITUTE

    MDR report key: 3221070 · Received July 2, 2013

    Report

    Report Number
    3007284313-2013-00051
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2011
    Report Date
    June 7, 2013
    Manufacturer
    W. L. GORE ASSOCIATES INC.
    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

    LITERATURE CITATION: NAGASO, N, ET AL. CAPSULE FORMATION CAN MAKE SECONDARY RECONSTRUCTION OF THE DURA MATER UNNECESSARY AFTER CRANIAL INFECTION, J CRANIOFAC SURG(TOKYO) 2011:22; 84-88.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "CAPSULE FORMATION CAN MAKE SECONDARY RECONSTRUCTION OF THE DURA MATER UNNECESSARY AFTER CRANIAL INFECTION" IT STATES A (B)(6) WOMAN HAD A DURAPLASTY USING A PTFE PATCH. TWO MONTHS LATER SHE DEVELOPED AN INFECTION. FOUR MONTHS AFTER THE INFECTION WAS DISCOVERED THE PATCH WAS REMOVED AND THE DEFECT WAS COVERED WITH A RECTUS ABDOMINUS MUSCLE FLAP. NO RECURRENCES OF INFECTION OR COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301040 GORE PRECLUDE DURA SUBSTITUTE GXQ/ DURA SUBSTITUTE GXQ W. L. GORE ASSOCIATES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R