BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 371103 · Received January 11, 2002

    Report

    Report Number
    2183620-2002-00001
    Event Type
    Other
    Date Received
    January 11, 2002
    Date of Event
    December 17, 2001
    Report Date
    December 20, 2001
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2001, PT UNDERWENT CRANIECTOMY WITH C1 LAMINECTOMY FOR REMOVAL OF A POSTERIOR FOSSA TUMOR. AT TIME OF IMPLANT, SURGEON SENT A PIECE OF STERILE DURA-GUARD DURAL REPAIR PATCH TO PATHOLOGY FOR FUNGAL CULTURE, AS IS THE PT'S ROUTINE. DURA-GUARD WAS IMPLANTED AND SURGERY WAS COMPLETED. THREE DAYS LATER, PATHOLOGY REPORTED POSITIVE FUNGAL GROWTH (CANDIDA PARAPSILOSIS) ON THE DURA-GUARD PATCH. THE PT WAS ASYMPTOMATIC FOR INFECTION. THE DURA-GUARD PATCH WAS SURGICALLY REMOVED THE NEXT DAY AND REPLACED WITH AUTOLOGOUS FASCIA LATA. SUBSEQUENT CULTURES OF THE EXPLANTED GRAFT HAVE BEEN NEGATIVE FOR FUNGAL GROWTH AND ALL OTHER ORGANISMS. THE PT WAS STARTED ON PROPHYLACTIC INTRAVENOUS MEDICATION AND ALL SUBSEQUENT PT CULTURES HAVE BEEN NEGATIVE FOR ANY ORGANISMS. AT NO TIME HAS THE PT PRESENTED ANY SIGN OR SYMPTOM OF INFECTION. THE PT WAS DISCHARGED 18 DAYS LATER AND IS REPORTED AS DOING VERY WELL BY THE PT'S SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-GUARD DURAL REPAIR PATCH GXQ BIO-VASCULAR, INC. DG-0404SN 537455

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R