BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL SEALANT SYSTEM 5ML (QTY 5) US

    MDR report key: 1652526 · Received April 1, 2010

    Report

    Report Number
    3003157248-2010-00005
    Event Type
    Injury
    Date Received
    April 1, 2010
    Report Date
    March 2, 2010
    Manufacturer
    CONFLUENT
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE DURASEAL IFU STATES: "THE DURASEAL DURAL SEALANT SYSTEM IS INTENDED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING CRANIAL SURGERY TO PROVIDE WATERTIGHT CLOSURE." THE IFU FURTHER CITES THE INCIDENCE OF CSF LEAKS IN THE CLINICAL STUDY: "THE INCIDENCE OF POST-OP CSF LEAKS IN THIS STUDY WAS 4.5%. OF THESE 1.8% WERE INCISIONAL AND 2.7% WERE PSEUDOMENINGOCELES." BENCH TOP TESTING HAS SHOWN THAT DURASEAL DOES NOT SUPPORT MICROBIAL GROWTH.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: POST SURGERY CEREBROSPINAL FLUID (CSF) LEAKS RESULTED IN AN INFECTION. THE SURGEON HAD TO RE-OPERATE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL SEALANT SYSTEM 5ML (QTY 5) US DURAL SEALANT NQR NQR CONFLUENT C101992-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention