BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS BIODESIGN DURAL GRAFT

    MDR report key: 1023381 · Received April 2, 2008

    Report

    Report Number
    1835959-2008-00001
    Event Type
    Injury
    Date Received
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K031850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE COULD NOT BE EVALUATED SINCE IT WAS NOT EXPLANTED. INFLAMMATION IS A COMMON KNOWN POTENTIAL COMPLICATION WHICH IS NOTED IN PRODUCT INSTRUCTIONS FOR USE. NO FURTHER INFO IS AVAILABLE. FLUID ACCUMULATION IS A COMMON OCCURENCE OF ANY MAJOR SURGERY.

    Description of Event or Problem · 1

    DR. USED DURASIS TO REPAIR A DURAL DEFECT AFTER REMOVING A HEMANGIOMA OF THE BRAIN. POSTOPERATIVELY, FLUID DEVELOPED AROUND THE DURASIS AREA, ABOVE AND BELOW THE DURAL LEVEL. THIS CREATED ENOUGH PRESSURE AGAINST THE BRAIN TO CREATE A SHIFT OF THE BRAIN. HE WAS CONCERNED THAT IT MIGHT BE AN ABSCESS, SO HE DRAINED IT THROUGH ANOTHER "BURR HOLE" IN THE SKULL. THE FLUID WAS A STERILE SEROMA. AFTER THE DECOMPRESSION, THE PT DID WELL. THE DURASIS WAS NOT REMOVED. THE PT CONTINUES TO DO WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISIS BIODESIGN DURAL GRAFT DURA SUBSTITUTE 21 CFR PART 882.5910 (GXQ) GXQ COOK BIOTECH, INC. DURASIS LB349589

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NONE KNOWN