BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 1

    MDR report key: 1883055 · Received October 15, 2010

    Report

    Report Number
    2648988-2010-00082
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 1 (DURS1391) WAS REPORTED TO HAVE BEEN FOUND WITH THE OUTER SLEEVE OF THE PACKAGE ALREADY OPENED AND A HAIR WAS FOUND STUCK TO THE OUTER SLEEVE OF THE PACKAGE. THE DURAGEN PACKAGE WAS NOTED TO BE OPENED BEFORE THE PRODUCT WAS PLACED ON THE STERILE FIELD AND BEFORE IT CAME IN CONTACT WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 1 NA GXQ INTEGRA NEUROSCIENCES PR 1101997

    Patients

    Seq Age Sex Outcome Treatment
    1