BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1211047 · Received October 24, 2008

    Report

    Report Number
    1625774-2008-00049
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO KCI RECORDS, THIS PATIENT WAS ON V.A.C. THERAPY MULTIPLE TIMES FROM 2007 UNTIL 2008. IT WAS REPORTED THAT THE PATIENT'S DRESSING CHANGES WERE PERFORMED BY THE WOUND CARE CLINIC ONCE A WEEK AND THE LONG TERM CARE CLINIC PERFORMED THE OTHER DRESSING CHANGES. THE DRESSING CHANGE SCHEDULE WAS REPORTED TO BE THREE TIMES PER WEEK. IT WAS REPORTED THAT THE WOUND CARE CLINIC DID HAVE PROCEDURES FOR DOCUMENTING PLACEMENT OF MORE THAN ONE PIECE OF FOAM AND THAT THE LONG TERM CARE FACILITY DID NOT HAVE PROCEDURES FOR DOCUMENTING FOAM PLACEMENT OR REMOVAL. V.A.C. LABELING WARNS UNDER "FOAM PLACEMENT": "DO NOT PLACE ANY FOAM DRESSING INTO BLIND/UNEXPLORED TUNNELS. THE V.A.C. WHITEFOAM DRESSING MAY BE MORE APPROPRIATE FOR USE WITH EXPLORED TUNNELS. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM USED IN THE WOUND AND DOCUMENT THAT NUMBER ON THE DRAPE AND IN THE PATIENT'S CHART." IT ALSO STATES UNDER "FOAM REMOVAL": V.A.C. FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES WAS REMOVED AS PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER INGROWTH OF TISSUE INTO THE FOAM, CREATE DIFFICULTY IN REMOVING THE FOAM FROM THE WOUND, AND LEAD TO INFECTION OR OTHER ADVERSE EVENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PERSISTENT PERINEAL SINUS FOR APPROXIMATELY ONE YEAR. THE WOUND WAS INFECTED AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. IT WAS REPORTED THAT DURING A SURGICAL EXPLORATION OF THE NON-HEALING PERINEAL WOUND, A PIECE OF BLACK FOAM WAS DISCOVERED IN A TUNNEL (15CM DEEP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM JCX KCI USA, INC. FREEDOM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention