BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILAYER MATRIX DRESSING 4X5 5 PACK

    MDR report key: 4122395 · Received September 18, 2014

    Report

    Report Number
    1121308-2014-00060
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 23, 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 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, (B)(4) 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 5TH METARSAL PHALANGEAL JOINT OF THE DORSOLATERAL FOOT, HAD A SURGICAL, DIABETIC NEUROPATHY ULCER ETIOLOGY. THE WOUND'S APPROXIMATE MEASUREMENT WAS DOCUMENTED AS 6.5 CM LENGTH, 4.5 CM WIDTH. 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. THE ACTION TAKEN WAS A COURSE OF INTRAVENOUS ANTIBIOTICS. THE SUBJECT WAS READMITTED ON (B)(6) 2013. THIS EVENT WAS DEEMED RESOLVED ON (B)(6) 2013 WHEN IRRIGATION AND DEBRIDEMENT, 5TH TOE AND METATARSAL AMPUTATION, AND APPLICATION OF A LOCAL FLAP (FILLET FLAP) ON THE 5TH TOE WERE PERFORMED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2013. A FOLLOW-UP VISIT ON (B)(6) 2013 DOCUMENTED THAT THERE WAS NO INFECTION IN OR AROUND THE TARGET WOUND. THE TARGET WOUND WAS DEEMED HEALED DURING A FOLLOW-UP ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578936 BILAYER MATRIX DRESSING 4X5 5 PACK BMWD FRO INTEGRA LIFESCIENCES CORP. 105B00262190

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R