BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAGEN 3X3 SINGLE EXPORT

    MDR report key: 1083580 · Received July 29, 2008

    Report

    Report Number
    1121308-2008-00012
    Event Type
    Other
    Date Received
    July 29, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 29, 2008
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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

    THE REPORTER STATED THAT TWO DEVICES THAT HAD PASSED THEIR EXPIRATION DATE HAD BEEN IMPLANTED DURING SURGERY. THE DEVICES BOTH HAVE THE SAME LOT NUMBER. THE PT WAS SUFFERING FROM MULTIPLE CRANIAL CONTUSIONS WITH CRANIAL SHIFT, SUSTAINED AFTER FALLING FROM BLEACHERS IN 2008. THE NURSE STATED THAT HIS CONDITION PRIOR TO SURGERY WAS EXTREMELY GRAVE, AND THAT THE SURGERY WAS A PALLIATIVE PROCEDURE. THE NURSE REPORTED THAT ON ENTERING SURGERY, THE PT'S PUPILS WERE FIXED AND DILATED, AND THAT HE DIED THE NEXT MORNING. THE REPORTER STATED THAT THE EXPIRATION DATES OF THE IMPLANTED DEVICES WERE NOT CHECKED PRIOR TO IMPLANTATION. HE STATED THAT THE USE OF THESE DEVICES WAS NOT LIKELY TO BE RELATED TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN 3X3 SINGLE EXPORT DURAL GRAFT MATRIX GXQ INTEGRA LIFESCIENCES 105BA0010758

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR