BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. DRESSING

    MDR report key: 3936052 · Received June 23, 2014

    Report

    Report Number
    3009897021-2014-00085
    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 ALLERGIC REACTION IS RELATED TO V.A.C. DRESSING. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFORMATION TO ESTABLISH A ROOT CAUSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: ACRYLIC ADHESIVE: THE V.A.C DRAPE HAS AN ACRYLIC ADHESIVE COATING, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC OR HYPERSENSITIVE TO ACRYLIC ADHESIVES. IF A PATIENT HAS A KNOWN ALLERGY OR HYPERSENSITIVITY TO SUCH ADHESIVES, DO NOT USE THE V.A.C THERAPY SYSTEM. IF ANY SIGNS OF ALLERGIC REACTION OR HYPERSENSITIVITY DEVELOP, SUCH AS REDNESS, SWELLING, RASH, URTICARIA, OR SIGNIFICANT PRURITUS, DISCONTINUE USE AND CONSULT A PHYSICIAN IMMEDIATELY. IF BRONCHOSPASM OR MORE SERIOUS SIGNS OF ALLERGIC REACTION APPEAR, SEEK IMMEDIATE MEDICAL ASSISTANCE.

    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) PATIENTS PLACED ON V.A.C. THERAPY EXPERIENCED AN ALLERGIC REACTION TO THE DRESSING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367032 V.A.C. DRESSING OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other