BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNK PRODUCT ID

    MDR report key: 2423257 · Received January 17, 2012

    Report

    Report Number
    1121308-2012-00001
    Event Type
    Injury
    Date Received
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NUMBERS - 1102027 AND 1102738. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE FIRST OF FOUR REPORTS OF SEIZURES FROM THE SAME FACILITY WITH THE USE OF DURAGEN PLUS 7.5 X 7.5 (PRODUCT ID-3301-I OR 3305-I) IN 2011. DURAGEN WAS NOT SUSPECTED WITH THE FIRST TWO PTS, BUT IT WAS REPORTED THAT THE SEIZURES IMMEDIATELY STOPPED RIGHT AFTER REMOVING THE DURAGENPLUS (THE DAY AFTER THE SURGERY). ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN-UNK PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORP. 1095511

    Patients

    Seq Age Sex Outcome Treatment
    1