BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C.® THERAPY

    MDR report key: 5105414 · Received September 25, 2015

    Report

    Report Number
    3009897021-2015-00091
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    January 31, 2013
    Report Date
    February 19, 2016
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STATEMENT IS TO CORRECT INFORMATION REPORTED IN INITIAL REPORT SENT ON SEP 25 2015.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S INCLUDED IN THIS STUDY WERE TREATED WITH NEGATIVE PRESSURE WOUND THERAPY FROM JAN 2007 TO JAN 2013. IT IS UNKNOWN WHEN THE EVENTS OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED WOUND DEHISCENCES WITH RETURN TO THE OR ARE RELATED TO V.A.C.® THERAPY. KCI HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, SO FAR WITHOUT SUCCESS. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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.

    Description of Event or Problem · 1

    ON AUG 28 2015, KCI RECEIVED ARTICLE, ADOGWA, O., FATEMI, P., PEREZ, E., MORENO, J., GAZCON, G., GOKASLAN, Z., BAGLEY, C. NEGATIVE PRESSURE WOUND THERAPY REDUCES INCIDENCE OF POSTOPERATIVE WOUND INFECTION AND DEHISCENCE AFTER LONG-SEGMENT THORACOLUMBAR SPINAL FUSION: A SINGLE INSTITUTIONAL EXPERIENCE. THE SPINE JOURNAL, 2911-2917, THAT REPORTED THREE PATIENTS DEVELOPED WOUND DEHISCENCE AND RETURNED TO THE OPERATING ROOM (OR) WHILE ON V.A.C. THERAPY. THE UNIT'S TYPE OR 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
    635271 V.A.C.® THERAPY OMP OMP KCI USA,INC. UNKVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R