BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM

    MDR report key: 1100821 · Received August 6, 2008

    Report

    Report Number
    3003157248-2008-00019
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    January 10, 2008
    Report Date
    July 7, 2008
    Manufacturer
    CONFLUENT
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS RECOVERED AND SHE IS DOING WELL. DR DOES NOT ATTRIBUTE EITHER OF THE LEAKS TO DURASEAL. 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."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A FEMALE PATIENT HAD INITIAL SURGERY IN EARLY 2008. THE SURGERY WAS PERFORMED FOR CHIARI MALFORMATION; LARGE POSTERIOR FOSSA. THE SURGEON HAD USED SURGICEL (J+J), DUREPAIR (MEDTRONIC) AND DURASEAL. THERE WAS A CSF LEAK AT 6 WEEKS POST-OP, REQUIRING A 2ND SURGERY, PERFORMED APPROXIMATELY LAST WEEK OF FEBRUARY. THE SURGEON USED THE SAME COMBINATION OF MATERIALS. THE PATIENT DEVELOPED ANOTHER CSF LEAK AT 6 WEEKS POST-OP ON 2ND SURGERY AND HAD TO GO IN FOR A 3RD SURGERY. ON 3RD SURGERY, AROUND THE 1ST WEEK IN APRIL, THE SURGEON DID NOT USE DURASEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL DURAL SEALANT SYSTEM DURAL SEALANT, NQR NQR CONFLUENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention