BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 16479573 · Received March 3, 2023

    Report

    Report Number
    3003418325-2023-00004
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 17, 2023
    Report Date
    March 17, 2023
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DURASEAL DURAL SEALANT (202050) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE ROOT CAUSE COULD NOT BE DETERMINED. PER THE FMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: PERFORMANCE, APPLICATION - GEL DELIVERY, AND SOLUTION MIXING AND COVERAGE. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT A PATIENT UNDERWENT "SUBOCCIPITAL CRANIECTOMY AND EXPANSILE DURAPLASTY" PROCEDURE, AND DURASEAL (202050) WAS APPLIED AFTER A DURAL PATCH (DURAGUARD) WAS SUTURED TO THE NATIVE DURA USING 5-0 PROLENE AND THE INCISION WAS CLOSED WITH 0-0 VICRYL FOR FASCIA, 2-0 VICRYL FOR DERMIS, AND SIMPLE RUNNING 4-0 PROLENE FOR SKIN. TWO WEEKS AFTER THE SURGERY, MODERATE CEREBROSPINAL FLUID (CSF) LEAKAGE OCCURRED. PRIOR TO RETURNING TO THE OPERATING ROOM FOR REVISION, DRESSINGS WERE BEING CHANGED EVERY 3 TO 4 HOURS AFTER BEING SOAKED FROM CLEAR DRAINAGE. AN ATTEMPT WAS MADE TO RE-SUTURE THE SKIN INCISION WHERE THE LEAK WAS OCCURRING; HOWEVER, IT DID NOT HOLD UP FOR LONG. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR REVISION OF THE LEK, AND A LUMBAR DRAIN WAS PLACED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946680 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown