BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C. THERAPY

    MDR report key: 3812797 · Received May 6, 2014

    Report

    Report Number
    3009897021-2014-00022
    Event Type
    Injury
    Date Received
    May 6, 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 PHYSICIAN REPORTED THE PATIENT WAS USING ANTIPLATELET AND ANTICOAGULANT MEDICATIONS UNDER CONTROLLED MANAGEMENT. THE PATIENT HAD ALSO TAKEN STEROIDS FOR AN EXTENDED PERIOD OF TIME WHICH CAUSED WEAKENED BLOOD VESSELS AND ALTERED CONNECTIVE TISSUE. THEREFORE, THE PATIENT WAS PRONE TO BLEEDING AND WOULD EXPERIENCE DIFFICULTY ARRESTING A HEMORRHAGE. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED HEMORRHAGING IS RELATED TO V.A.C. THERAPY. THE PATIENT WAS TAKING STEROIDS, AND WAS PRONE TO BLEEDING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO KCI BY THE (B)(4) REPRESENTATIVE: AT THE (B)(4), THE PHYSICIAN REPORTED THAT ONE MONTH PRIOR TO THE FIRST CLINICAL VISIT, THE PATIENT FELL DOWN AT HOME AND CLINICAL VISIT, THE PATIENT FELL DOWN AT HOME AND DEVELOPED A SUBCUTANEOUS HEMATOMA. ON THE PATIENT'S FRONT RIGHT KNEE, BLACK NECROTIC TISSUE MEASURING 4-5CM WAS NOTED. A DEBRIDEMENT WAS PERFORMED, AND V.A.C. THERAPY WAS STARTED. AFTER THE THIRD DRESSING CHANGE, COAGULATED BLOOD WAS OBSERVED UNDER THE V.A.C. DRAPE. WITHIN 12 HOURS, 400ML OF BLOODY DRAINAGE WAS OBSERVED IN THE CANISTER, AND THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK. THE PATIENT'S WOUND WAS CAUTERIZED, AND THE PATIENT RECEIVED A BLOOD TRANSFUSION. THREE MONTHS LATER, GOOD GRANULATION TISSUE FORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271662 ACTIV.A.C. THERAPY OMP KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALFADEX| LIMAPROST| ASPIRIN| PREDNISONE