BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2051075 · Received April 5, 2011

    Report

    Report Number
    1625774-2011-00045
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS STILL IN USE WITH THE PATIENT. THEREFORE, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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 EITHER V.A.C. GRANUFOAM OR V.A.C. WHITE FOAM DRESSING 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 HEALTHCARE PROVIDER: ON (B)(6) 2010, ACTIV.A.C. THERAPY WAS INITIATED. ON (B)(6) 2011, DURING A DRESSING CHANGE, A PIECE OF WHITE FOAM THAT WAS PLACED ON THE PREVIOUS DRESSING CHANGE COULD NOT BE LOCATED. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO AN OUTPATIENT SURGICAL FACILITY FOR REMOVAL OF THE WHITE FOAM UNDER GENERAL ANESTHESIA. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION. ON (B)(6) 2011, ACTIV.A.C. THERAPY WAS RESUMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R