BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 315567 · Received February 8, 2001

    Report

    Report Number
    2183620-2001-00004
    Event Type
    Other
    Date Received
    February 8, 2001
    Date of Event
    January 19, 2001
    Report Date
    January 22, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2000, PT UNDERWENT REPAIR OF ARNOLD-CHIARI MALFORMATION WITH IMPLANTATION OF A DURA-GUARD GRAFT. IN 2001, PT COMPLAINED OF HEADACHE, VOMITING AND NECK PAIN. SURGEON INITIALLY SUSPECTED AN ALLERGIC REACTION TO THE DURA-GUARD AND CONTACTED BIO-VASCULAR FOR INFO REGARDING INCIDENCE AND TREATMENT. THE SURGEON WROTE HE CANNOT DIRECTLY ATTRIBUTE THE EVENT TO DURA-GUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4738 DURA-GUARD DURAL REPAIR PATCH GXQ BIO-VASCULAR DG-0404S 527441

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other