BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3830241 · Received May 7, 2014

    Report

    Report Number
    3009897021-2014-00030
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 10, 2014
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED WITH NEGATIVE PRESSURE WOUND THERAPY DURING THE (B)(6) 2010 TO (B)(6) 2013 TIME PERIOD. IT IS UNKNOWN WHEN THE EVENT OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THA THE ALLEGED "APPLICATION TROUBLE" OR PARTIAL NECROSIS IS RELATED TO V.A.C. THERAPY. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. CONTINUOUS THERAPY IS ALSO GENERALLY RECOMMENDED FOR PATIENTS AT INCREASED RISK OF BLEEDING, HIGHLY EXUDATING WOUNDS, FRESH FLAPS AND GRAFTS, AND WOUNDS WITH ACUTE ENTERIC FISTULAE. CONTINUOUS THERAPY FOR DURATION OF 7 DAYS WITH NO DRESSING CHANGES IS ALSO GENERALLY RECOMMENDED FOR USE OF V.A.C. THERAPY WITH A NEW GRAFT PLACEMENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO KCI BY THE KCI KK REPRESENTATIVE: AT THE 57TH ANNUAL MEETING OF (B)(4) OF PLASTIC RECONSTRUCTIVE SURGERY, THE PHYSICIAN REPORTED DURING THE TIME PERIOD OF (B)(6) 2010 TO (B)(6) 2013 (EXACT DATE OF EVENT WERE NOT PROVIDED), V.A.C. THERAPY WAS USED AS A BOLSTER DRESSING POST SKIN GRAFT PLACEMENT. A PATIENT EXPERIENCED "APPLICATION TROUBLE" WHILE ON V.A.C. THERAPY THAT ALLEGEDLY CAUSED PARTIAL SKIN NECROSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274782 V.A.C. THERAPY OMP KCI USA, INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other