BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1344298 · Received March 13, 2009

    Report

    Report Number
    1625774-2009-00027
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 11, 2009
    Report Date
    February 11, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE WOUND CARE NURSE, THERE WAS NO PRODUCT MALFUNCTION REPORTED OR ALLEGED. KCI RECORDS INDICATE V.A.C. THERAPY WAS INITIATED IN 2009. THE WOUND CARE NURSE INDICATED THAT THE WOUND WAS HIGHLY EXUDATING. THE WOUND CARE NURSE FURTHER INDICATED THAT THE PRESSURE HAD BEEN INCREASED WHEN MACERATION DEVELOPED DUE TO THE PT'S HIGHLY EXUDATING WOUND. THE WOUND CARE NURSE STATED THAT THE DRESSING CHANGES ARE BEING PERFORMED ONCE PER WEEK BY THE PROFESSIONAL CAREGIVER AND TWICE PER WEEK BY A FAMILY CAREGIVER. V.A.C. LABELING STATES "IF THE WOUND APPEARS WHITE, EXCESSIVELY MOIST OR MACERATED: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS. FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. THE EXUDATE VOLUME SHOULD EXPERIENCE A GRADUAL DECREASE AS THE EXTRACELLULAR DEBRIS IS BROUGHT TO EQUILIBRIUM. DETERMINE IF OCCULT INFECTION IS PRESENT. INCREASE PRESSURE SETTINGS BY 25 MMHG INCREMENTS IF INCREASED DRAINAGE. DETERMINE IF THERE IS A POSITIONAL SEAL LEAK, WHICH MAY BE PREVENTING EFFECTIVE EXUDATE REMOVAL. EVALUATE DRESSING TECHNIQUE. ASSESS FOR THE NEED TO BRIDGE SENSAT.R.A.C./T.R.A.C. PAD AWAY FROM THE WOUND. PROTECT THE SURROUNDING TISSUE WITH V.A.C. DRAPE OR A HYDROCOLLOID. ISOLATE WOUND DRAINAGE FROM PERIWOUND SKIN. DETERMINE IF PT IS ADEQUATELY OFF-LOADED OR IF THERE IS A POTENTIAL FOR EXTERNAL PRESSURE ON THE WOUND/DRESSING, WHICH MAY CAUSE THE WOUND EXUDATE TO BE FORCED ONTO THE PERIWOUND SKIN." THE UNIT NOR THE DRESSING HAS BEEN RETURNED TO KCI FOR EVAL AS THE PT CONTINUES TO RECEIVE THERAPY AS OF THE DATE OF THIS REPORT, AND NO MALFUNCTION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2009 THAT A PT WHO WAS RECEIVING V.A.C. THERAPY FOR A SURGICAL LATERAL FOOT WOUND ALLEGEDLY EXPERIENCED MACERATION WHICH REQUIRED A SURGICAL DEBRIDEMENT. KCI RECORDS INDICATE THAT THE PT CONTINUES WITH V.A.C. THERAPY AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM ACCESSORY TO JCX. JCX KCI USA, INC. V.A.C. DRESSING NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention