BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. DRESSING

    MDR report key: 3929215 · Received June 30, 2014

    Report

    Report Number
    3009897021-2014-00096
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    May 28, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C. 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. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. 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 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, 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 EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE.

    Description of Event or Problem · 1

    ON MAY 28 2014, KCI RECEIVED ARTICLE, AHMED F., SWAN M. C., FLYNN M., TIERNAN E.P., RETAINED VAC THERAPY SPONGE AS A COMPLICATION OF ABDOMINOPLASTY. JOURNAL OF PLASTIC RECONSTRUCTIVE & AESTHETIC SURGERY (2010) 63. E497-E499, THAT REPORTED THAT ONE (1) PATIENT HAD RETAINED FOAM, ALLEGED TO BE V.A.C. DRESSING, LEFT IN THEIR WOUND. THE PATIENT UNDERWENT GASTRIC BYPASS SURGERY AND WAS PLACED ON V.A.C. THERAPY AFTER THE PATIENT EXPERIENCED A WOUND INFECTION. THE PATIENT WAS TREATED WITH "INTRAVENOUS CO-AMOXYCLAV". THREE (3) DAYS LATER, THE PATIENT PRESENTED WITH GROWTH OF STAPHYLOCOCCUS AUREUS. V.A.C. THERAPY WAS REMOVED AND "THE PATIENT WAS DISCHARGED AFTER TWO DAYS HAVING MADE AN UNEVENTFUL RECOVERY". UPON FOLLOW UP, THE PATIENT COMPLAINED OF A "LUMPY SCAR WHICH CAUSED HER INTERMITTENT DISCOMFORT. ON PALPATION, THERE WERE FIRM NON-TENDER SUBCUTANEOUS MASSES DEEP TO THE TRANSVERSE LIMB OF THE ABDOMINOPLASTY SCAR THAT WERE THOUGHT TO REPRESENT RESIDUAL FAT NECROSIS". THE PATIENT UNDERWENT A REVISION ABDOMINOPLASTY. UPON EXAMINATION FOREIGN BODIES, ALLEGED TO BE V.A.C. DRESSING, WERE EXCISED. THE PATIENT "WAS PLEASED WITH THE POST-OPERATIVE RESULT AND WAS DISCHARGED FOLLOWING THREE-MONTH REVIEW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378689 V.A.C. DRESSING OMP KCI USA INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention