BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 X 3 SUTURABLE DURAGEN

    MDR report key: 1040443 · Received May 8, 2008

    Report

    Report Number
    1121308-2008-00008
    Event Type
    Injury
    Date Received
    May 8, 2008
    Report Date
    May 6, 2008
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION AND INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    DURING THE INTRODUCTION OF THE SUTURABLE DURAGEN TO THE SURGEON AT THIS FACILITY, IT WAS COMMUNICATED THAT HE HAD EXPERIENCED CEREBROSPINAL FLUID LEAKS AND DISINTEGRATION OF THE PRODUCT TWO YEARS PREVIOUSLY AT ANOTHER INSTITUTION. HE DECIDED BASED UPON HIS EXPERIENCE, NOT TO USE THE PRODUCT. INTEGRA HAS COMPLAINTS FOR THE PAST 2 YEARS AND NO REPORTED INCIDENT HAS BEEN SUBMITTED BY EITHER THIS RESIDENT OR FROM THIS PREVIOUS HOSPITAL. THE DEVICE INVOLVED IN THIS INCIDENT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 X 3 SUTURABLE DURAGEN NONE GXQ INTEGRA LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1