BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2932238 · Received January 25, 2013

    Report

    Report Number
    3009897021-2012-00007
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 26, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE VAC WHITEFOAM DRESSING WAS INADVERTENTLY LEFT IN THE WOUND. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THERE WAS NO ALLEGED PRODUCT MALFUNCTION. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: ON AN UNKNOWN DATE, THE PT WAS ADMITTED TO THE HOSPITAL DUE TO AN INFECTION. ON (B)(6) 2012, UPON BEDSIDE DEBRIDEMENT, THE PHYSICIAN OBSERVED AND REMOVED TWO PIECES OF 3 CM FOREIGN MATERIAL ALLEGED TO BE VAC WHITEFOAM DRESSING FROM THE WOUND BED. IT WAS ALSO REPORTED THAT, ON AN UNKNOWN DATE, THE HOME HEALTH NURSES HAD OBSERVED THE PERIWOUND SKIN BECOMING RED AND INDURATED, WHICH WAS REPORTED TO THE PHYSICIAN. UPON FOLLOW-UP ON (B)(6) 2013, THE NURSE ALLEGED THE PT'S INFECTION AND HOSPITALIZATION WERE RELATED TO THE RETAINED FOREIGN MATERIAL WHICH SUBSEQUENTLY REQUIRED SURGICAL EXCISION. THE NURSE STATED THE PERIWOUND REDNESS AND INDURATION WERE RELATED TO THE WOUND INFECTION. THE PT WAS TREATED WITH ANTIBIOTIC THERAPY. THE PT CONTINUED TO RECEIVE VAC THERAPY AND IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36326 V.A.C. THERAPY OMP KCI USA, INC. V.A.C. WHITEFOAM

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention