BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL SEALANT SYSTEM 5ML (QTY 5) US

    MDR report key: 2202373 · Received August 3, 2011

    Report

    Report Number
    1219930-2011-00619
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 8, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: EXPLORATION ON POSTOPERATIVE DAY 10 REVEALED THAT THE SEALANT WAS CAUSING CAUDA EQUINA COMPRESSION PROXIMAL TO THE SITE OF THE DUROTOMY. DURASEAL GEL WAS PLACED OVER THE LEAK. A TOTAL VOLUME OF APPROXIMATELY 3 ML WAS APPLIED. HOWEVER, ONCE FULLY EXPANDED, EXCESS DURASEAL WAS REMOVED. ORIGINAL LEG PAIN HAD RETURNED AND THE PATIENT WAS CONFINED TO BED WITH PROGRESSIVE BACK AND LEFT LEG PAIN. ON DAY 9 POSTOPERATIVE, HE WAS READMITTED AND MR IMAGING WAS REPEATED. TEN DAYS AFTER THE INITIAL DISCECTOMY, REVISION SURGERY WAS PERFORMED. A LARGE AMOUNT OF BLUE DURASEAL MATERIAL WAS VISUALIZED. AFTER REMOVING DURASEAL, THE CSF LEAK RECURRED. THIS WAS SEALED WITH A SMALL RECTANGLE OF DURASEAL AND RECTANGLES OF THIN GELATIN SPONGE. AFTER SURGERY, THE PATIENT'S NEUROLOGIC STATUS WAS NORMAL. PATIENT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL SEALANT SYSTEM 5ML (QTY 5) US DURASEAL SEALANT NQR UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other