BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 X 5 SUTURABLE DURAGEN

    MDR report key: 646412 · Received September 30, 2005

    Report

    Report Number
    1121308-2005-00031
    Event Type
    Malfunction
    Date Received
    September 30, 2005
    Report Date
    September 30, 2005
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INTEGRA REP REPORTED ON BEHALF OF THE USER FACILITY THAT SUTURABLE DURAGEN WAS USED TO REPAIR A CHIARI MALFORMATION. THE PT REQUIRED A RE-OPERATION. WHEN THE REPAIR/REVISION WAS PERFORMED, THE SUTURABLE DURAGEN WAS GONE. THE DETAILED INFO WAS OBTAINED LATER FROM THE USER FACILITY: THE PT ORIGINALLY HAD A REPAIR OF A CHIARI MALFORMATION AND PHYSICIAN APPLIED DURAGUARD (NOT AN INTEGRA PRODUCT, MANUFACTURED BY BIO-VASCULAR, INC). THE PHYSICIAN OBSERVED GRANULOMA AROUND THE EDGE OF THE DURAGUARD AND PSEUDOMENINGOCELE. PHYSICIAN REOPERATED AND PLACED SUTURABLE DURAGEN AND DURASEAL (NOT AN INTEGRA PRODUCT, MANUFACTURED BY CONFLUENT SURGICAL, INC) AROUND THE 4.0 SILK SUTURE LINES. PHYSICIAN PERFORMED A RUNNING SUTURE. ONE WEEK POST OP, PT DEVELOPED A CSF LEAK. THE SURGEON WENT BACK IN AT WHICH TIME IT WAS OBSERVED THAT THE SUTERABLE DURAGEN HAD DISSOLVED EXCEPT FOR THE STITCHES. DURAGUARD WAS ONCE AGAIN PLACED AND THE PT IS REPORTEDLY DOING FINE. THE THREE PROCEDURES WERE REPORTED TO HAVE OCCURRED WITHIN ONE MONTH'S TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 X 5 SUTURABLE DURAGEN SUTURABLE DURAGEN GXQ INTEGRA LIFESCIENCES CORP. * 105B00046309

    Patients

    Seq Age Sex Outcome Treatment
    1 *