BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1884036 · Received October 14, 2010

    Report

    Report Number
    1625774-2010-00095
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    July 8, 2009
    Report Date
    September 16, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN BODY WAS NOT RETURNED TO KCI FOR IDENTIFICATION THEREFORE KCI WAS UNABLE TO CONFIRM IDENTITY OF THE FOREIGN OBJECT. KCI IS FILING THIS REPORT DUE TO POSSIBLE USE ERROR AS A FOREIGN BODY ALLEGED TO BE A KCI PRODUCT WAS LEFT IN THE PATIENT'S WOUND AND REQUIRED SURGICAL INTERVENTION TO REMOVE. V.A.C. THERAPY LABELING AVAILABLE IN PRINT AND ON-LINE STATES "V.A.C. FOAM DRESSING ARE NOT ABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES WAS REMOVED AS PLACED. FORM 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT ABDOMINAL SURGERY FOR ENDOMETRIAL CANCER. ON (B)(6) 2009, THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF INCISION DRAINING OPEN WOUND OF ABDOMINAL WALL ANTERIOR. INFOVAC THERAPY WAS PRESCRIBED AND APPLIED IN THE HOSPITAL. ON (B)(6) 2009, THE PATIENT WAS TRANSFERRED TO A LONG TERM CARE FACILITY AND THE VAC FREEDOM THERAPY UNIT WAS PLACED ON THE PATIENT AT THE LONG TERM CARE FACILITY. ON (B)(6) 2009, VAC FREEDOM THERAPY WAS DISCONTINUED. ON (B)(6) 2010, THE PATIENT'S WOUND WAS NOT HEALING AND WAS ADMITTED TO THE OPERATING ROOM AND PLACED UNDER GENERAL ANESTHESIA TO EXPLORE THE WOUND. THE SURGEON'S NURSE REPORTS THAT DURING THIS PROCEDURE A SINGLE PIECE OF MATERIAL, DOCUMENTED BY THE SURGEON TO POSSIBLY BE VAC GRANUFOAM DRESSING, WAS REMOVED FROM THE PATIENT'S ABDOMEN, SIZE AND SHAPE OF THE MATERIAL WAS NOT SPECIFIED. ACCORDING TO THE HOSPITAL, THEY DO HAVE A PROTOCOL FOR COUNTING FOAM PLACED IN THE WOUND ALTHOUGH IT IS UNKNOWN WHETHER THAT PROTOCOL WAS UTILIZED IN THIS SITUATION. IT WAS UNKNOWN IF THE LONG TERM CASE FACILITY HAD A PROTOCOL FOR COUNTING FOAM PLACED IN THE WOUND. ON AN UNKNOWN DATE, THE PATIENT'S ABDOMINAL WOUND HEALED.

    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 54 YR Required Intervention