BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3936062 · Received June 23, 2014

    Report

    Report Number
    3009897021-2014-00083
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTIONS ARE RELATED TO V.A.C. THERAPY. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE.

    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 FIVE (5) PTS PLACED ON V.A.C. THERAPY DEVELOPED AN INFECTION. NO ADD'L INFO IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367342 V.A.C. THERAPY OMP KCI USA INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other