BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2633786 · Received June 26, 2012

    Report

    Report Number
    1625774-2012-00055
    Event Type
    Injury
    Date Received
    June 26, 2012
    Date of Event
    January 1, 2012
    Report Date
    May 29, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT 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 ANASTAMOSES OR GRAFTS)/ORGAN; 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 THE TREATING PHYSICIAN. ALWAYS ENSURE THAT V.A.C. FOAM DRESSINGS DO NOT COME IN DIRECT CONTACT WITH VESSELS OR ORGANS. USE OF A THICK LAYER OF NATURAL TISSUE SHOULD PROVIDE THE MOST EFFECTIVE PROTECTION. IF A THICK LAYER OF NATURAL TISSUE IS NOT AVAILABLE OR IS NOT SURGICALLY POSSIBLE, MULTIPLE LAYERS OF FINE-MESHED, NON-ADHERENT MATERIAL OR BIO-ENGINEERED TISSUE MAY BE CONSIDERED AS AN ALTERNATIVE, IF DEEMED BY THE TREATING PHYSICIAN TO PROVIDE A COMPLETE PROTECTIVE BARRIER. IF USING NON-ADHERENT MATERIALS, ENSURE THEY ARE SECURED IN A MANNER THAT WILL MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY. IT IS A CONTRAINDICATION OF V.A.C. THERAPY TO PLACE FOAM DRESSING OF THE V.A.C. THERAPY SYS DIRECTLY IN CONTACT WITH EXPOSED BLOOD VESSELS, ANASTOMOTIC SITES, ORGANS, OR NERVES."

    Description of Event or Problem · 1

    ON (B)(6) 2012, KCI BECAME AWARE OF AN ARTICLE IN THE INTL WOUND JOURNAL ENTITLED: "ACUTE MEDIASTINAL BLEEDING DURING VACUUM-ASSISTED CLOSURE" WHICH REPORTED THE FOLLOWING: ON DAY 19 OF V.A.C. THERAPY THE PT ALLEGEDLY HAD MEDIASTINAL BLEEDING. THE PT HAD SURGERY TO REPAIR AN ANASTOMOSIS OF A HEART VESSEL. THE PT RECOVERED AND WAS DISCHARGED IN GOOD CONDITION. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO GAIN ADD'L INFO ON THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention FOR 6 WEEKS.| ON AN UNK DATE THE PT WAS PRESCRIBED CEFTAZIDIME