BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 262216 · Received February 10, 2000

    Report

    Report Number
    2183620-2000-00004
    Event Type
    Other
    Date Received
    February 10, 2000
    Date of Event
    February 2, 2000
    Report Date
    February 10, 2000
    Manufacturer
    BIO-VASCULAR
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A DURA-GUARD DURAL REPAIR DURING A CRANIOTOMY FOR A MENINGIOMA IN 1999. TWO MONTHS LATER, PT COMPLAINED OF PERSISTENT HEADACHES, AND CEREBRAL EDEMA/ENLARGMENT WERE NOTED ON AN MAGNETIC RESONANCE IMAGING SCAN. THE PT BEGAN STEROID THERAPY. THE DEVICE HAS NOT BEEN EXPLANTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-GUARD DURAL REPAIR PATCH GXQ BIO-VASCULAR DG 0608S DGS 96J18-052

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention