BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3940123 · Received June 19, 2014

    Report

    Report Number
    3009897021-2014-00074
    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 EVENTS OCCURRED AS THIS INFO HAS NOT BEEN PROVIDED. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED ADVERSE EVENTS RELATED TO V.A.C. THERAPY. KCI HAS MADE SEVERAL ATTEMPTS TO DETERMINE THE NATURE OF THE ALLEGED ADVERSE EVENTS. NO ADD'L INFO IS AVAILABLE.

    Description of Event or Problem · 1

    KCI RECEIVED ARTICLE, ARMSTRONG, D.G. NEGATIVE PRESSURE WOUND THERAPY AFTER PARTIAL DIABETIC FOOT AMPUTATION: A MULTICENTRE, RANDOMISED CONTROLLED TRIAL. LANCET (2005) 366: 1704-10 THAT REPORTED THAT ONE PT PLACED ON V.A.C. THERAPY EXPERIENCED AN SERIOUS ADVERSE EVENT. 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
    359578 V.A.C. THERAPY OMP KCI USA INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other