BEUDAMED
    FDA Adverse Event Death Summary report: N

    BILAYER MATRIX WOUND DRESSING 4 X 5 5 PACK

    MDR report key: 4129283 · Received September 10, 2014

    Report

    Report Number
    1121308-2014-00055
    Event Type
    Death
    Date Received
    September 10, 2014
    Date of Event
    November 11, 2012
    Report Date
    August 13, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    FRO
    PMA / PMN Number
    K021792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(4) 2014. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: THE PRODUCT WAS NOT RETURNED, THEREFORE, NO FAILURE ANALYSIS COULD BE COMPLETED FOR THIS COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 105NB0248229 REVEALED THERE WERE NO ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESS REVIEW THAT COULD BE ATTRIBUTABLE TO THE FAILURE MODE OF "INFECTION" OBSERVED. (B)(4). CONCLUSION: ROOT CAUSE. DURING THE DHR REVIEW, THERE WERE NO ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD BE ATTRIBUTABLE TO THE FAILURE MODE OF "INFECTION" OBSERVED. SINCE THE PRODUCT WAS NOT RETURNED, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED AS PART OF "A RETROSPECTIVE, MULTI-CENTER STUDY EVALUATING THE OUTCOMES FOR INTEGRA SKIN SHEET BILAYER OR SINGLE LAYER PRODUCTS USED IN COMPLEX LOWER EXTREMITY SOFT TISSUE RECONSTRUCTION." IT WAS REPORTED SUBJECT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012. SUBJECT UNDERWENT IRRIGATION AND DÉBRIDEMENT AND BONE RESECTION OF LEFT TRANSMETATARSAL AMPUTATION STUMP. THE SUBJECT'S WOUND HAD A SURGICAL ETIOLOGY. THE WOUND'S APPROXIMATE MEASUREMENT WAS 8 CM LENGTH, 4.5 CM WIDTH. ON (B)(6) 2012, SUBJECT UNDERWENT IRRIGATION AND DÉBRIDEMENT AND THE SUBJECT RECEIVED INTEGRA WITH NEGATIVE PRESSURE WOUND THERAPY (NPWT). SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE SUBJECT HAD AN ADVERSE EVENT OF AN INFECTION THOUGHT TO BE CAUSED BY THE TARGET WOUND. ON (B)(6) 2012 THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SEPSIS, AND DIED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559678 BILAYER MATRIX WOUND DRESSING 4 X 5 5 PACK BMWD FRO INTEGRA LIFESCIENCES CORP. 105NB0248229

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death