BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 X 3 SUTURABLE DURAGEN

    MDR report key: 2190170 · Received June 5, 2007

    Report

    Report Number
    1121308-2007-00006
    Event Type
    Injury
    Date Received
    June 5, 2007
    Report Date
    June 6, 2007
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE MARKETING DIRECTOR REPORTED ON BEHALF OF THE USER FACILITY, HAVING SPOKEN WITH THE PHYSICIAN THE FOLLOWING INCIDENT: THE PHYSICIAN HAD OPERATED ON A PATIENT SEVERAL WEEKS AGO TO REMOVE A FOURTH VENTRICULAR EPENDYMOMA, AND USED SUTURABLE DURAGEN TO REPAIR THE DURA. THE PATIENT DEVELOPED A PSEUDOMENINGOCELE. UPON RE-EXPLORATION, A SMALL HOLE HAD FORMED IN THE MIDDLE OF THE GRAFT (SUTURABLE DURAGEN SHEET). THE PHYSICIAN REPLACED THE GRAFT WITH A SECOND SUTURABLE DURAGEN GRAFT AND THE USED DURASEAL FOR SECONDARY CLOSURE. THIS INCIDENT IS RELATED TO MDR# 1121308-2007-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 X 3 SUTURABLE DURAGEN DURAGEN GXQ INTEGRA LIFESCIENCES DURS3391 105B00079972

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention