BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURA NO-REACT DURAL SUBSTITUTE, 4 CM X 4 CM

    MDR report key: 952935 · Received November 14, 2007

    Report

    Report Number
    3003418325-2007-00020
    Event Type
    Injury
    Date Received
    November 14, 2007
    Report Date
    November 14, 2007
    Manufacturer
    SHELHIGH, INC.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORP IS FILING A DISTRIBUTOR REPORT BASED UPON INFO PROVIDED BY THE USER FACILITY. THE MFR, SHELHIGH, INC. WILL BE NOTIFIED VIA EMAIL OF THE REPORTED COMPLAINT AND PROVIDED WITH A COPY OF THIS REPORT VIA FEDEX.

    Description of Event or Problem · 1

    ON 10/24/07 INTEGRA LIFESCIENCES RECEIVED A LETTER FROM THE FDA INDICATING THAT A VOLUNTARY MEDWATCH HAD BEEN FILED ON THE ENDURA DURAL GRAFT. THE FOLLOWING INFO WAS REPORTED, "INCIDENT DATE: 2005; MEDWATCH REPORT; CRANIOTOMY FOR FORAMEN MAGNUM TUMOR, DURA PATCH GRAFT APPLIED. FDA RECALL OF PRODUCT ENVIRONMENT CONTROLS FAILED AND COMPROMISED THE STERILITY OF PRODUCT. ONE MONTH LATER, REVISION OF WOUND DUE TO INFECTION." ADDITIONAL INFO OBTAINED: A REVIEW OF THE COMPLAINT DATABASE FROM 10/1/04 TO PRESENT DOES NOT INDICATE THAT INTEGRA WAS AWARE OF THE INCIDENT. AN INTEGRA REP SPOKE TO THE REP FROM THE USER FACILITY ON 10/29/07 TO OBTAIN ADDITIONAL INFO AND A COPY OF THE MEDWATCH FILED. THE USER FACILITY DID NOT RETAIN A COPY OF THE MEDWATCH IN THEIR FILES. THE REP AT THE USER FACILITY STATED THAT THEY CANNOT IMPLICATE ENDURA AS THE CAUSE OF THE INCIDENT. THE MEDWATCH FILING WAS THE RESULT OF A VOLUNTARY RECALL AND NOT DUE TO THE HEALTH PROFESSIONAL OR PT REPORTING THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURA NO-REACT DURAL SUBSTITUTE, 4 CM X 4 CM ENDURA GXQ SHELHIGH, INC. * 66623

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization