BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL SEALANT SYSTEM 5ML (QTY 5) US

    MDR report key: 1582054 · Received January 14, 2010

    Report

    Report Number
    3003157248-2010-00001
    Event Type
    Injury
    Date Received
    January 14, 2010
    Report Date
    December 18, 2009
    Manufacturer
    CONFLUENT SURGICAL,INC
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/14/2010, THE SURGEON REPORTED THAT "THE PATIENT'S PROGNOSIS IS FAIR. SHE HAS RESIDUAL DEFECTS BUT THEY HAVE IMPROVED SINCE THE SECOND SURGERY." THE DHR REVIEW CONFIRMED THAT LOT C070695-01 MET THE REQUIRED SPECIFICATIONS AT LOT RELEASE. NOTE: SWELLING OF THE DURASEAL IS A NORMAL CONDITION. THE DURASEAL IFU, LISTS THE FOLLOWING CONTRAINDICATION: "DO NOT APPLY THE DURASEAL HYDROGEL TO CONFINED BONY STRUCTURES WHERE NERVES ARE PRESENT SINCE NEURAL COMPRESSION MAY RESULT DUE TO HYDROGEL SWELLING. THE HYDROGEL MAY SWELL UP TO 50% OF ITS SIZE IN ANY DIMENSION."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SURGEON HAD A RECENT UNSATISFACTORY EXPERIENCE WITH DURASEAL. THE CASE WAS A T3 LAMINECTOMY TO PLACE A SHUNT INTO THE SPINAL CORD. THE DURA WAS SUTURED CLOSED. THE SURGEON APPLIED DURASEAL AND BELIEVED THE THICKNESS TO BE A FEW MMS. THE SURGERY OCCURRED AND THE PATIENT WAS DISCHARGED POST-OP DAY TWO. THE PATIENT WENT TO ER AFTER EXPERIENCING SOME PARALYSIS. INITIAL DIAGNOSIS WAS A POTENTIAL HEMATOMA. THE PATIENT UNDERWENT A RE-OPERATION. THE SURGEON STATED THAT THE ORIGINAL DURASEAL TREATED AREA CONTAINED A CLEAR, GELATIN-LIKE MATERIAL WHICH WAS 10+ MM THICK. HE ATTRIBUTED THE GELATIN-LIKE MATERIAL TO DURASEAL. THE MATERIAL WAS REMOVED. THE PATIENT RECOVERED SOME MOBILITY, BUT MAY STILL EXPERIENCE PARTIAL PARAPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL SEALANT SYSTEM 5ML (QTY 5) US DURAL SEALANT NQR NQR CONFLUENT SURGICAL,INC C070695-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention