BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 337146 · Received June 11, 2001

    Report

    Report Number
    2183620-2001-00014
    Event Type
    Other
    Date Received
    June 11, 2001
    Date of Event
    March 19, 2001
    Report Date
    May 3, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001 PT HAD LEFT PARIETAL MENINGIOMA. APPROXIMATELY 2 WEEKS LATER PT EXPERIENCED SEIZURES AND STATUS EPILILPTICUS. PT WAS RE-HOSPITALIZED, INTUBATED, AND RECEIVED ANTICONVULSANT MEDICATIONS. PT WAS HOSPITALIZED FOR 1 MONTH AND NOW DOING MUCH BETTER WITH RESOLUTION OF PARIETAL EDEMA AS DEMONSTRATED BY MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26738 DURA-GUARD DURAL REPAIR PATCH DSY BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R