BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3936048 · Received June 23, 2014

    Report

    Report Number
    3009897021-2014-00084
    Event Type
    Injury
    Date Received
    June 23, 2014
    Report Date
    May 21, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE EVENT OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED MACERATION EVENTS ARE RELATED TO V.A.C. THERAPY. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFORMATION TO ESTABLISH A ROOT CAUSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

    Description of Event or Problem · 1

    KCI RECEIVED ARTICLE, ARMSTRONG, D.G., MARSTON, W.A. REYZELMAN, A.M, KIRSNER, R.S. COMPARATIVE EFFECTIVENESS OF MECHANICALLY AND ELECTRICALLY POWERED NEGATIVE PRESSURE WOUND THERAPY DEVICES: A MULTICENTER RANDOMIZED CONTROLLED TRIAL. WOUND REP REG (2012) 332-341, THAT REPORTED THAT THIRTEEN (13) PATIENTS PLACED ON V.A.C. THERAPY EXPERIENCED MACERATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367129 V.A.C. THERAPY OMP KCI USA INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other