BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 5211607 · Received November 9, 2015

    Report

    Report Number
    3009897021-2015-00103
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 13, 2015
    Report Date
    February 5, 2016
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THIS CORRECTION, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED HEMORRHAGING IS RELATED TO V.A.C.® THERAPY.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED HEMORRHAGING IS RELATED TO V.A.C.® THERAPY.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED HEMORRHAGING IS RELATED TO V.A.C. THERAPY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL CLINICAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WITH OR WITHOUT USING V.A.C. THERAPY, CERTAIN PATIENTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PATIENTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. · PATIENTS 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)/ORGAN INFECTION TRAUMA RADIATION PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS PATIENTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS PATIENTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES. IF V.A.C. THERAPY IS PRESCRIBED FOR PATIENTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE 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 CANISTER, 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

    ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2015, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY: THE FAMILY MEMBER ALLEGEDLY OBSERVED RED BLOOD DRIPPING FROM THE PATIENT'S WOUND. ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT REPORTED GOING TO THE EMERGENCY ROOM ON (B)(6) 2015 DUE TO THE BLEEDING WHERE HE RECEIVED A STITCH WITH A DRESSING CHANGE. THE PATIENT CONFIRMED NO BLOOD TRANSFUSION WAS REQUIRED AND IS REPORTEDLY DOING FINE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741326 ACTIV.A.C.® THERAPY OMP OMP KCI USA,INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention