BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C.ULTA¿ THERAPY

    MDR report key: 6029904 · Received October 14, 2016

    Report

    Report Number
    3009897021-2016-00088
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    August 18, 2016
    Report Date
    October 14, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THE THAT THE ALLEGATION THAT THE STRATTICE IMPLANTED BY THE SURGEON THAT WAS FOUND TO BE GONE IN THE MIDDLE DURING THERAPY REMOVAL AND THE PATIENT'S SUBSEQUENT RE-HERNIATION ARE RELATED TO V.A.C.ULTA THERAPY. THERE HAVE BEEN MULTIPLE ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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. MAINTAINING A SEAL. -FOR DELICATE PERIWOUND TISSUE OR IN AREAS THAT ARE DIFFICULT TO DRESS, APPLY PROTECTIVE SKIN PREPARATION AND FRAME THE WOUND WITH TRANSPARENT FILM OR HYDROCOLLOID DRESSING OR OTHER APPROPRIATE BARRIER. -POSITION THE DRESSING TUBING ON FLAT SURFACES AND AWAY FROM THE PERINEAL AREA, BONY PROMINENCES OR PRESSURE AREAS. ENSURING DRESSING INTEGRITY IT IS RECOMMENDED THAT A CLINICIAN OR PATIENT (IN THE HOME) VISUALLY CHECK THE DRESSING EVERY TWO HOURS TO ENSURE THAT THE FOAM IS FIRM AND COLLAPSED IN THE WOUND BED WHILE THERAPY IS ACTIVE. IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: -CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. -CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. -EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. -CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. -EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE. NEVER LEAVE A V.A.C. DRESSING IN PLACE WITHOUT ACTIVE V.A.C. THERAPY FOR MORE THAN 2 HOURS. IF THERAPY IS OFF FOR MORE THAN 2 HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C. DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C. THERAPY; OR APPLY AN ALTERNATIVE DRESSING AT THE DIRECTION OF THE TREATING CLINICIAN. CONTINUOUS THERAPY IS ALSO GENERALLY RECOMMENDED FOR PATIENTS AT INCREASED RISK OF BLEEDING, HIGHLY EXUDATING WOUNDS, FRESH FLAPS AND GRAFTS, AND WOUNDS WITH ACUTE ENTERIC FISTULAE. CONTINUOUS THERAPY FOR DURATION OF 7 DAYS WITH NO DRESSING CHANGES IS ALSO GENERALLY RECOMMENDED FOR USE OF V.A.C. THERAPY WITH A NEW GRAFT PLACEMENT.

    Description of Event or Problem · 1

    ON SEP 15 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE LIFECELL REPRESENTATIVE: ON (B)(6) 2016, THE SURGEON USED STRATTICE TO REPAIR A VENTRAL HERNIA AND PLACED V.A.C.ULTA THERAPY. AFTER ONE WEEK POST-OP, THE MIDDLE PORTION OF THE STRATTICE WAS COMPLETELY GONE, BUT THE OUTER EDGES WERE STILL IMPLANTED. ON SEP 16 2016, ADDITIONAL INFORMATION WAS REPORTED TO KCI BY THE LIFECELL REPRESENTATIVE: THE PHYSICIAN REPORTED THAT CONTAMINATION WAS PRESENT WHEN STRATTICE WAS IMPLANTED. ONE WEEK POST-OP, THE MID PORTION OF GRAFT WAS OBSERVED TO BE "COMPLETELY GONE". HE ASKED IF IT WAS DUE TO THE CONTAMINATED FIELD OR IF IT WAS DUE TO THE V.A.C.ULTA THERAPY PLACED. ADAPTIC WAS PLACED WITH THE V.A.C.ULTA THERAPY. RE-HERNIATION OCCURRED IN THE MID SECTION OF STRATTICE. ON SEP 20 2016, ADDITIONAL INFORMATION WAS REPORTED TO KCI BY THE LIFECELL REPRESENTATIVE: THERE WAS NO INFECTION PRESENT. A BOWEL RESECTION WAS ALSO PERFORMED WITH THE HERNIA REPAIR WHICH LED TO THE CONTAMINATION. ONE WEEK POST-OP, WHEN THE SURGEON WENT TO REMOVE THE V.A.C.ULTA THERAPY, HE NOTICED THAT THE STRATTICE WAS GONE IN THE MIDDLE AND THE PATIENT SUBSEQUENTLY REHERNIATED. THE PATIENT IS CURRENTLY IN THE HOSPITAL AWAITING A HERNIA REPAIR. THE OUTER PORTIONS OF THE STRATTICE⠒REMAIN IMPLANTED AND THE SURGEON PLANS TO REPAIR THE REHERNIATION AT A LATER TIME WITH ANOTHER PIECE OF STRATTICE. THE UNIT SERIAL NUMBER WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682394 V.A.C.ULTA¿ THERAPY OMP OMP KCI USA, INC. WNDULT SP100250-162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other