BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 7544148 · Received May 25, 2018

    Report

    Report Number
    3003418325-2018-00027
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    December 18, 2017
    Report Date
    December 26, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORP
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    A REGULATORY AFFAIRS STAFF REPORTED THAT AFTER ASSEMBLY AND USE INSTRUCTIONS WERE DULY FOLLOWED, THE LIQUID ON A 202050 DURASEAL DURAL SEALANT SYSTEM WAS NOT CONSOLIDATED AND FLOWED DOWN AFTER INJECTING ON THE PATIENT. AFTER "SUCKING IN" THE UNCONSOLIDATED LIQUID, THE SURGEON USED A NEW DURASEAL KIT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 INDICATING THAT ON (B)(6) 2018, THE DURASEAL WAS USED ON A FEMALE PATIENT DURING A CEREBELLUM HEMANGIOMA PROCEDURE. THE PATIENT WAS ANESTHETIZED WHEN THE PROBLEM OCCURRED. THERE WAS A DELAY OF 10 MINUTES DUE TO PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386313 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA LIFESCIENCES CORP N7E0090X

    Patients

    Seq Age Sex Outcome Treatment
    1