BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD

    MDR report key: 508955 · Received January 14, 2004

    Report

    Report Number
    MW1030839
    Event Type
    Injury
    Date Received
    January 14, 2004
    Date of Event
    December 14, 2001
    Report Date
    January 13, 2004
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CARINIOTOMY FOR RESECTION OF A POSTERIOR FOSSA TUMOR. THE NEUROSURGEON SENT PART OF THE DURAGRAFT FOR BIOPSY ALONG WITH THE TUMOR. THREE DAYS LATER THE NEUROSURGEON REFERRED DR. FOR INFECTIOUS DISEASE CONTROL, TO PT. HE EXPLAINED THAT THE DURA GRAFT GREW OUT SEVERAL COLONIES OF YEAST (CANDIDA PARAPSILOSIS) AND HE RECOMMENDED STARTING ABELCET BY I.V. IMMEDIATELY ALONG WITH SURGERY ASAP TO REMOVE THE CONTAMINATED MATERIAL. DR. WAS UNSURE IF THE ABLESET WOULD WORK BECAUSE HE STATED HE HAD NEVER DEALT WITH THIS TYPE OF INFECTION BEFORE OR THE CIRCUMSTANCES SURROUNDING IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| L| R| S (1) MORPHINE BY I.V. (2) TYLENOL (3) IBUPROFIN| (4) ANTIBIOTICS.