BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL SEALANT SYSTEM 5ML (QTY 5) US

    MDR report key: 3836028 · Received May 13, 2014

    Report

    Report Number
    1219930-2014-00368
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: DISCECTOMY. ACCORDING TO THE RPTR: RECURRENT L2-L3 HNP. L2-L3 DISCECTOMY. LUMBAR SPINE. DISCECTOMY FOR RECURRENT HNP DONE (B)(6) 2014. SMALL DURAL TEAR NOTED. DURASEAL UTILIZED. PT HAD COMPLETE RESOLUTION OF LEG PAIN POST OP. SEVERAL DAYS POST OP BEGAN DEVELOPING CAUDA EQUINA SYNDROME DISCOVERED ON F/U CALL (B)(6) 2014. EMERGENCY WORKUP LED TO URGENT SURGICAL EXPLORATION. CONCERN IS THAT DURASEAL ENLARGEMENT CAUSED A MECHANICAL COMPRESSION AND/OR TOXIC INFLAMMATION RESULTING IN THE DELAYED NEUROLOGIC SEQUELAE. PROFOUND NEURO DEFICITS IN BOTH LE. TWO SUBSEQUENT SURGERIES TO REMOVE ALL DURASEAL AND SUBSEQUENTLY APPLY EPIDURAL STEROID. PROFOUND NEURO DEFICIT AT THIS TIME, SOME RECOVERY NOTED, FINAL OUTCOME PENDING. INCISION EXTENDED ABOUT 1 1/2 INCHES. PT RETURNED TO OPERATING ROOM FOR URGENT SURGICAL DECOMPRESSION. THIRD TRIP TO OPERATING ROOM INCLUDED APPLICATION OF EPIDURAL STEROIDS TO AREA OF DURAL. HYDROGEL INDUCED CAUDA EQUINA SYNDROME. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS TISSUE DAMAGE. THE INCISION WAS EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. NO DEVICE FRAGMENT FELL INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285091 DURASEAL SEALANT SYSTEM 5ML (QTY 5) US DURASEAL SEALANT NQR COVIDIEN, FORMERLY US N3D0380X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other