BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2031085 · Received March 22, 2011

    Report

    Report Number
    1625774-2011-00039
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 23, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES VAC FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF PIECES OF FOAM WAS REMOVED AS PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER IN-GROWTH OF TISSUE INTO THE FOAM AND CREATE DIFFICULTY IN REMOVING FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. BASED ON INFORMATION PROVIDED BY THE HEALTH CARE PROVIDERS IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C. GRANUFOAM WAS INADVERTENTLY LEFT IN THE WOUND. THE FOREIGN BODY WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI WAS UNABLE TO CONFIRM IDENTITY OF THE FOREIGN OBJECT. THERE WAS NO PRODUCT MALFUNCTION. THIS REPORT IS BEING FILED DUE TO USER MISUSE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE DOCTOR'S NURSE: ON (B)(6) 2011, THE PATIENT WAS PLACED ON V.A.C. THERAPY. ON (B)(6) 2011, THE PATIENT WAS DISCONTINUED FROM V.A.C. THERAPY AND WAS ADMITTED TO THE HOSPITAL DUE TO URINARY TRACT INFECTION WITH SEPSIS, HYPONATREMIA, AND ANEMIA THAT WERE UNRELATED TO V.A.C. THERAPY. THE PATIENT SHOWED SIGNS AND SYMPTOMS OF INCREASED DRAINAGE FROM THE LEFT ISCHIAL PRESSURE ULCER WITH NO ABSCESS OR CELLULITIS NOTED. ON (B)(6) 2011, A DEBRIDEMENT OF THE WOUND WAS DONE IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA, AND PIECES OF FOREIGN MATERIAL WERE FOUND IN THE WOUND. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention