BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILAYER MATRIX WOUND DRESSING 4X5 SINGLE

    MDR report key: 4122404 · Received September 18, 2014

    Report

    Report Number
    1121308-2014-00059
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 1, 2013
    Report Date
    August 25, 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

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED AS PART OF "A RETROSPECTIVE, MULT-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 RECEIVED INTEGRA, WITH NEGATIVE PRESSURE WOUND THERAPY (NPWT), AND IRRIGATION AND DEBRIDEMENT ON (B)(6) 2013. THE SUBJECT'S WOUND, WHICH WAS ON THE RIGHT PLANTAR FOOT, AND HAD A SURGICAL, DIABETIC NEUROPATHY ULCER ETIOLOGY. THE WOUND'S APPROXIMATE MEASUREMENT WAS DOCUMENTED AS 10 CM LENGTH, 3.5 CM WIDTH, WITH A DEPTH TO THE BONE. ON (B)(6) 2013, THE SUBJECT HAD AN ADVERSE EVENT OF AN INFECTION. THIS EVENT WAS DOCUMENTED AS SEVERE IN SEVERITY AND POSSIBLY RELATED TO THE INITIAL INDEX TREATMENT WITH INTEGRA. IT WAS CONSIDERED A SERIOUS ADVERSE EVENT. ON (B)(6) 2013, THE SUBJECT WAS READMITTED. ON (B)(6) 2013, IRRIGATION AND DEBRIDEMENT OF THE TARGET WOUND WAS PERFORMED. ON (B)(6) 2013, A LEFT ANGIOGRAM WAS PERFORMED. THE TARGET WOUND WAS NOT A SUITABLE TARGET FOR REVASCULARIZATION ON THIS DATE. ON (B)(6) 2013 IRRIGATION AND DEBRIDEMENT OF THE TARGET WOUND WAS PERFORMED, FOLLOWED BY A MID-FOOT (LISFRANC) AMPUTATION. PURULENCE AND NECROSIS WERE PRESENT AT THE MARGIN, AND A BELOW KNEE AMPUTATION WAS RECOMMENDED. THIS EVENT IS DEEMED RESOLVED ON (B)(6) 2013 WHEN A BELOW KNEE GUILLOTINE AMPUTATION WAS PERFORMED. ON (B)(6) 2013 A BELOW KNEE AMPUTATION REVISION AND CLOSURE SURGERY WAS PERFORMED. THERE ARE NO ADDITIONAL FOLLOW-UP VISITS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578939 BILAYER MATRIX WOUND DRESSING 4X5 SINGLE BMWD FRO INTEGRA LIFESCIENCES CORP. 105A00271922

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R