BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL SEALANT SYSTEM 5ML (QTY 5) US

    MDR report key: 1621098 · Received February 22, 2010

    Report

    Report Number
    3003157248-2010-00004
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Report Date
    January 25, 2010
    Manufacturer
    CONFLUENT
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IN THE ARTICLE IN THE JOURNAL "NEUROSURGERY," NOV 2009, WAS NOT A REPORT OF A CONTROLLED STUDY, BUT WAS A RETROSPECTIVE REVIEW OF PRIOR CASES. THE ARTICLE INDICATED THAT THE CASES IN WHICH IMPLANTATION OF MULTIPLE PRODUCTS WERE USED FOR DURAL CLOSURE MAY REPRESENT THE SURGEON'S RECOGNITION OF A SITUATION WITH INHERENTLY HIGH RISK OF POSTOPERATIVE CSF LEAK. THE ARTICLE CONCLUDED THAT PTS WHO REQUIRE ADD'L NON-AUTOLOGOUS MATERIALS TO EFFECT CLOSURE OF THE CRANIOTOMY SITE, SUCH AS DURAL SEALANTS AND CRANIOPLASTY MATERIALS, ARE AT INCREASED RISK OF POST OPERATIVE CSF LEAK. NO CONCLUSIONS SHOULD BE DRAWN REGARDING CAUSALITY. AN ARTICLE IN THE JOURNAL OF NEUROSURGERY: SEP 2007 CONCLUDED THAT DURASEAL SEALANT APPLIED WITH COLLAGEN BASED DURAL GRAFTS SIGNIFICANTLY REDUCED CSF LEAKAGE. AN ARTICLE IN JOURNAL OF NEUROSURGERY: JUL 2009 CONCLUDED THAT DURASEAL SEALANT IS EFFECTIVE WHEN USED FOR WATERTIGHT DURAL CLOSURE IN CONJUNCTION WITH NON-AUTOLOGOUS DURAPLASTY MATERIALS.

    Description of Event or Problem · 1

    AN ARTICLE IN THE JOURNAL "NEUROSURGERY," NOV 2009, REPORTED THAT IN A RETROSPECTIVE STUDY OF NEUROSURGICAL PROCEDURE USING A COLLAGEN SPONGE DURAPLASTY AND USING DURASEAL SURGICAL SEALANT, IT WAS FOUND THAT IN 13% OF THE CASES, THERE WERE POSTOPERATIVE CSF LEAKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1