BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL SEALANT 5ML POLYMER KIT, X1

    MDR report key: 2945765 · Received February 1, 2013

    Report

    Report Number
    1219930-2013-00058
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    August 6, 2012
    Report Date
    January 9, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CRANIOTOMY. ACCORDING TO THE REPORTER: THIS IS THE REPORT OF ADVERSE EVENT WHICH OCCURRED IN THE CLINICAL RESEARCH, "POSTOPERATIVE MULTI-CENTER POST MARKET SURVEILLANCE OF THE EFFICACY AND THE SAFETY OF THE DURASEAL DURAL SEALANT SYSTEM IN A CRANIOTOMY". PRIMARY DISEASE: VESSEL MALFORMATION OF SPINAL CORD. AFTER SURGERY FOR GALLSTONE AND GASTRIC CANCER, HE SUFFERS MALUM COXAE, TOO. HYPOSTATIC CRANIAL NERVE PALSY, RIGHT HEMIPLEGIA, AND LEFT SENSORY DISTURBANCE. (MMR4/5) ON (B)(6) 2012, THE SUBOCCIPITAL CRANIOTOMY WAS PERFORMED TO REACH THE LESION UNDER TENTORIUM CEREBELLI. SIZE OF INCISION: 10.0 CM. COMBINATION THERAPY: IRRIGATION WITH ANTIBIOTIC AND ICG ADMINISTRATION. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. IN (B)(6), FLUID RETENSION WAS CONFIRMED BY CT. IT WAS DIAGNOSED AS CEREBROSPINAL FLUID LEAK ASSOCIATED WITH SPINAL CORD INJURY. THE PT RECOVERED FROM IT SOON DURING F/U, BUT INFARCTION WAS ALSO FOUND AND TREATED WITH STEROID ADMINISTRATION. IT WAS DIAGNOSED AS AN ADVERSE EVENT CAUSED BY THE PROCEDURE. ON (B)(6), THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL TO TAKE REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45171 DURASEAL SEALANT 5ML POLYMER KIT, X1 DURASEAL NQR COVIDIEN, FORMERLY US SURGICAL N2A0075X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other