BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. DRESSING

    MDR report key: 3940138 · Received June 19, 2014

    Report

    Report Number
    3009897021-2014-00066
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    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 ALLERGIC REACTION IS RELATED TO V.A.C. DRESSING. 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 ONE PT PLACED ON V.A.C. THERAPY EXPERIENCED AN ALLERGIC REACTION TO THE DRESSING. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359462 V.A.C. DRESSING OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other