BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3940135 · Received June 19, 2014

    Report

    Report Number
    3009897021-2014-00062
    Event Type
    Injury
    Date Received
    June 19, 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

    IT IS UNK WHEN THE EVENT OCCURRED AS THIS INFO HAS NOT BEEN PROVIDED. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INCREASE IN WOUND SIZE IS 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. COMPARISON OF NEGATIVE PRESSURE WOUND THERAPY WITH AN ULTRAPORTABLE MECHANICALLY POWERED DEVICE VS TRADITIONAL ELECTRICALLY POWERED DEVICE FOR THE TREATMENT OF CHRONIC LOWER EXTREMITY ULCERS: A MULTICENTER RANDOMIZED-CONTROLLED TRIAL. WOUND REP REG (2011) 173-180 THAT REPORTED THAT TWO PTS PLACED ON V.A.C. THERAPY EXHIBITED AN INCREASE IN WOUND SIZE DURING THE STUDY. 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
    359461 V.A.C. THERAPY OMP KCI USA INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other