BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 4696926 · Received April 15, 2015

    Report

    Report Number
    3009897021-2015-00026
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    April 4, 2015
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S INCLUDED IN THIS STUDY WERE TREATED WITH NEGATIVE PRESSURE WOUND THERAPY FROM MAR 2003 TO AUG 2008. IT IS UNKNOWN WHEN THE EVENTS OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FISTULAS ARE RELATED TO V.A.C. THERAPY. THE PATIENTS HAD A SIGNIFICANT HISTORY OF ABDOMINAL COMPLICATIONS REQUIRING SEVERAL SURGICAL INTERVENTIONS. KCI HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, SO FAR WITHOUT SUCCESS.

    Description of Event or Problem · 1

    KCI RECEIVED ARTICLE, JAMES HORWOOD, FAYAZ AKBAR, ANDREW MAW INITIAL EXPERIENCE OF LAPAROSTOMY WITH IMMEDIATE VACUUM THERAPY IN PATIENTS WITH SEVERE PERITONITIS, ANN R COLL SURG ENGL. 2009; 91:681-687, DOI: 10.1308/003588409X12486767520993 THAT REPORTED TWO PATIENTS DEVELOPED ENTEROCUTANEOUS FISTULAS WHILE ON NEGATIVE PRESSURE THERAPY. ONE FISTULA WAS DISCOVERED DURING A SECOND-LOOK LAPAROTOMY. A SECOND LOW OUTPUT FISTULA WAS FOUND FOR A PATIENT, WHO HAD UNDERGONE A SMALL BOWEL RESECTION AND ANASTOMOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251452 V.A.C. THERAPY OMP OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention