BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3223769 · Received July 10, 2013

    Report

    Report Number
    3009897021-2013-00066
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE V.A.C. VERAFLO DRESSING WAS PLACED INTO THE PT'S INTRAPERITONEAL AREA. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: V.A.C. 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 ARE 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. DRESSING CHANGES: WOUNDS BEING TREATED WITH THE V.A.C. THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, THE V.A.C. DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVAL OF THE WOUND CONDITION AND THE PT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: ON (B)(6) 2013, UPON PERFORMING A DRESSING CHANGE, A FOREIGN MATERIAL ALLEGED TO BE V.A.C. VERAFLO DRESSING, HAD BROKEN INTO PIECES AND ADHERED TO THE WOUND BED REQUIRING DEBRIDEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317879 V.A.C. THERAPY OMP KCI USA INC. VERAFLO DRESSING

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention