BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS - ADHESION BARRIER MATRIX 10.0 CM X

    MDR report key: 7183571 · Received January 11, 2018

    Report

    Report Number
    1121308-2018-00001
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 5, 2017
    Report Date
    December 13, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K092388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON 08FEB2018: THE UNITS WERE NOT RETURNED DUE TO THEIR CONDITIONS AFTER THEY WERE REMOVED FROM THE PATIENT. HOWEVER, THE RESULTS OF THE RETAIN SAMPLES EVALUATION WERE SATISFACTORY; NO SIGNS OF DETERIORATION WERE OBSERVED ON THE SPONGES AND A GOOD SEAL (CONTINUOUS AND EVENLY COMPRESSED) ALONG THE ENTIRE SEAL LENGTH WAS OBSERVED ON EACH PACKAGING TRAY. THE BACTERIAL ENDOTOXIN TEST OF ALL RETAIN SAMPLES HAD ACCEPTABLE RESULTS; RESULTS MET THE PRODUCT SPECIFICATION OF < 0.0625 EU/ML. THE REPORTED CONDITION OF FEVER COULD NOT BE RELATED TO THE MANUFACTURING PROCESSES OF THE FINISHED GOODS (FG) LOTS 1150315 AND 1162467. ACCORDING TO THE DHR REVIEW FG LOTS 1150315 AND 1162467, NO ANOMALIES WERE REPORTED DURING THEIR MANUFACTURING AND PACKAGING PROCESSES THAT COULD BE RELATED TO THE REPORTED CONDITION. THERE ARE CONTROLS IN PLACE DURING THE PROCESS SUCH AS GOWNING, CONTROLLED AREAS, AREA AND PRODUCT MONITORING, AND VALIDATED STERILIZATION CYCLES TO PREVENT THIS TYPE OF EVENTS, THEREFORE, THERE IS NO INDICATION THAT THE ROOT CAUSE FOR THE REPORTED CONDITION IS RELATED TO THE DURAGEN PRODUCT. THE ROOT CAUSES FOR THE REPORTED CONDITIONS (FEVER AND YELLOWISH IN COLOR, CHARACTERISTIC OF INFECTION) ARE UNDETERMINED AND THE REPORTED CONDITIONS ARE UNCONFIRMED.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 2. A DISTRIBUTOR REPORTED THAT ON (B)(6) 2017, A (B)(6) PATIENT WITH BILATERAL CRANIAL TRAUMA UNDERWENT A BILATERAL CRANIOTOMY FOR HEMATOMA DRAINAGE AND DECOMPRESSION. TWO UNITS OF DURAGEN WERE IMPLANTED AT THAT TIME. AFTER 11 DAYS (B)(6) 2017), THE PATIENT PRESENTED WORSENING FEVER AND OTHER SYMPTOMS RELATED TO INFECTION. ON (B)(6) 2017, THE PATIENT EXPERIENCED INTRACRANIAL HYPERTENSION. THE PATIENT RETURNED TO SURGERY, HAD THE IMPLANTED DURAGENS REMOVED WITH SURGICAL CLEANING. IT WAS REPORTED THAT ¿THE PRODUCTS REMOVED WERE YELLOWISH IN COLOR, CHARACTERISTIC OF AN INFECTION¿. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER ON 14DEC2017 WITH THE FOLLOWING, "THE PATIENT IS IN THE INTENSIVE CARE UNIT (ICU) IN AN INDUCED COMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26571 DURAGEN PLUS - ADHESION BARRIER MATRIX 10.0 CM X N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1150315

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Other| R