BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN DURAL GRAFT MATRIX

    MDR report key: 3190212 · Received June 21, 2013

    Report

    Report Number
    1121308-2013-00033
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    PMA / PMN Number
    K092388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE TOPIC OF THE RECENT DURAGEN RECALL WAS DISCUSSED. DURING THE DISCUSSION TWO OF THE NEUROSURGEONS REPORTED THAT THE NEUROSURGEONS HAD RECENTLY HAD 4-5 PATIENTS WHO HAD CONTRACTED POST SURGICAL CHEMICAL MENINGITIS. THEY ARE NOT SUGGESTING THAT DURAGEN WAS THE CAUSE OF THIS AND THEY HAVE STATED THEY DIDN'T THINK IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283199 DURAGEN DURAL GRAFT MATRIX NA GXQ INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1