BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2994364 · Received March 5, 2013

    Report

    Report Number
    3009897021-2012-00026
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE. THE UNIT'S SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADD'L INFO, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRIOR AND ONLINE, STATES: WITH OR WITHOUT USING V.A.C. THERAPY, CERTAIN PTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. PTS WHO HAVE WEAKENED OR FRIABLE BLOOD VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTOMOSIS OR GRAFTS/ORGANS, INFECTION, TRAUMA, RADIATION, PTS WITHOUT ADEQUATE WOUND HEMOSTASIS, PTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS. PTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES. IF V.A.C. THERAPY IS PRESCRIBED FOR PTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY TREATING PHYSICIAN. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING V.A.C. THERAPY, OR IF FRANK (BRIGHT RED) BLOOD IS SEEN IN THE TUBING OR IN THE CATHETER, IMMEDIATELY STOP V.A.C. THERAPY, LEAVE DRESSING IN PLACE, TAKE MEASURES TO STOP THE BLEEDING AND SEEK IMMEDIATE MEDICAL ASSISTANCE. THE V.A.C. THERAPY UNITS AND DRESSINGS SHOULD NOT BE USED TO PREVENT, MINIMIZE OR STOP VASCULAR BLEEDING.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PHYSICIAN: A FEW PRIOR TO (B)(6) 2013, DATE NOT SPECIFIED, A PT WITH A GRADE II TIBIAL FRACTURE HEMORRHAGED 850CC OF BLOOD, AND UNDERWENT AN AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93886 V.A.C. THERAPY OMP KCI USA INC. INFOV.A.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention