BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 885959 · Received July 27, 2007

    Report

    Report Number
    1625774-2007-00026
    Event Type
    Injury
    Date Received
    July 27, 2007
    Date of Event
    June 25, 2007
    Report Date
    June 26, 2007
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEALTH CARE PROVIDER INDICATES THAT THE OPERATING DOCTOR THOUGHT HE MIGHT BE PERFORMING AN INCISION AND DRAINAGE OF A NECROTIC TUMOR, BUT DISCOVERED THE FOAM. THE HEALTH CARE PROVIDER FURTHER INDICATED THAT "TWO STRIPS OF MATERIAL IDENTIFIED AS FOAM THAT WOULD BE USED IN TUNNELS WITH BLACK V.A.C. FOAM" WERE FOUND. AT THE TIME OF THE INCISION AND DRAINAGE, THE PATIENT RECEIVED AN ANTIBIOTIC (ANCEF) PREOPERATIVELY AND AN ANTIBIOTIC (VANCOMYCIN) POSTOPERATIVELY. FOLLOWING THE PROCEDURE TO REMOVE THE FOAM, THE PATIENT WAS AGAIN PLACED ON V.A.C THERAPY. THE PATIENT HAS RECEIVED V.A.C THERAPY THIRTY EIGHT DAYS IN 2004. THE DRESSING CHANGES WERE DONE BY MULTIPLE CAREGIVERS AT MULTIPLE CARE SETTINGS INCLUDING THE HOSPITAL AND THE HOME SETTING. V.A.C. LABELING STATES UNDER "WARNINGS": "V.A.C. FOAM DRESSINGS ARE NOT BIOABSORBABLE. ENSURE THAT ALL PIECES OF FOAM HAVE BEEN REMOVED FROM THE WOUND WITH EACH DRESSING CHANGE. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY INCREASE INGROWTH OF TISSUE INTO THE FOAM, CREATE DIFFICULTY IN REMOVING FOAM FROM THE WOUND, OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS". IT ALSO STATES: "ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES WERE REMOVED AS PLACED".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT THAT HAD RECEIVED V.A.C. THERAPY IN 2004 HAD AN INCISION AND DRAINAGE OF AN ABSCESS OF THE LEFT BREAST. DURING THE INCISION AND DRAINAGE, PIECES OF WHITE FOAM WERE FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention