BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILAYER MATRIX WOUND DRESSING 4X5 5 PACK

    MDR report key: 4093247 · Received September 3, 2014

    Report

    Report Number
    1121308-2014-00048
    Event Type
    Other
    Date Received
    September 3, 2014
    Date of Event
    September 11, 2012
    Report Date
    August 8, 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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    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 THE SUBJECT RECEIVED INTEGRA, WITH IRRIGATION AND DEBRIDEMENT ON (B)(6) 2012. THE SUBJECT'S WOUND, WHICH WAS ON THE RIGHT PLANTAR FOOT, HAD A PUNCTURE WOUND ETIOLOGY. THE WOUND'S APPROXIMATELY MEASUREMENT WAS 5.5 CM LENGTH, 3 CM WIDTH, 1.2CM DEPTH. ON (B)(6) 2012 THE SUBJECT HAD AN ADVERSE EVENT OF DEHISCENCE. THIS EVENT WAS DOCUMENTED AS MODERATE IN SEVERITY AND POSSIBLY RELATED TO THE INITIAL INDEX TREATMENT WITH INTEGRA. IT WAS NOT CONSIDERED A SERIOUS ADVERSE EVENT. THE ACTION TAKEN WAS LOCAL WOUND CARE. THIS ADVERSE EVENT WAS LISTED AS ONGOING, BUT FOLLOW-UP VISITS DID NOT SHOW ANY ADD'L EVENTS OF DEHISCENCE. ALSO ON (B)(6) 2012, THE SUBJECT WAS READMITTED WITH AN ADVERSE EVENT OF FUNGEMIA ASSOCIATED WITH FUNGAL INFECTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE (UNRELATED TO THE TARGET WOUND). THIS EVENT WAS DOCUMENTED AS SEVERE IN SEVERITY AND NOT RELATED TO THE INITIAL INDEX TREATMENT WITH INTEGRA. IT WAS CONSIDERED A SERIOUS ADVERSE EVENT. THE ACTION TAKEN WAS CONCOMITANT THERAPY WITH INTRAVENOUS ANTIFUNGALS. THIS EVENT WAS DEEMED RESOLVED ON (B)(6) 2012. AS OF (B)(6) 2013, THE TARGET WOUND HAD NOT HEALED. THERE IS NO ADD'L FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535388 BILAYER MATRIX WOUND DRESSING 4X5 5 PACK BMWD FRO INTEGRA LIFESCIENCES CORP. 105A00251481

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other