BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURABLE DURAGEN DURAL REGEN MATRIX

    MDR report key: 2211081 · Received August 5, 2011

    Report

    Report Number
    1121308-2011-00029
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THERE WAS A REPORT OF A CEREBROSPINAL FLUID LEAKAGE WITH SUTURABLE DURAGEN IN THE POSTERIOR FOSSE AND SUPERNATANT AREAS 15 DAYS POST OPERATIVELY. THE SPECIFIC PRODUCT COULD NOT BE IDENTIFIED; HOWEVER, IT IS BELIEVED THAT IT COULD EITHER BE (DURS 2291-ITL OR DURS 3391-ITL) THE PT HAD TO RETURN TO THE HOSPITAL AS A RESULT OF THE LEAKAGE. IT WAS REPORTED THAT THIS WAS NOT RELATED TO A DRAINAGE ISSUE OR HYDROCEPHALUS CONSEQUENCES. THE SUTURABLE DURAGEN WAS USED FOLLOWING INTEGRA LIFESCIENCES GUIDELINES WITH MINIMUM SUTURE TENSION; NO SEALANT WAS USED WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURABLE DURAGEN DURAL REGEN MATRIX NA GXQ INTEGRA, PLAINSBORO

    Patients

    Seq Age Sex Outcome Treatment
    1