BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1242930 · Received November 21, 2008

    Report

    Report Number
    1625774-2008-00058
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 28, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE WOUND CARE NURSE, THERE WAS NO PRODUCT MALFUNCTION AND THE HEALTHCARE PROFESSIONALS WERE TRAINED IN THE USE OF V.A.C. THERAPY. THE WOUND CARE NURSE IN CHARGE OF THE PATIENT STATED THAT V.A.C. THERAPY WAS STARTED TO SOON AFTER SURGICAL DEBRIDEMENT. THIS CASE IS BEING REPORTED BECAUSE THE CONDITION OF THE PATIENT REQUIRED MEDICAL INTERVENTION TO RESOLVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT HOSPITALIZED WITH ENDOCARDITIS BEING TREATED WITH V.A.C. THERAPY FOR A COCCYX STAGE IV PRESSURE ULCER EXPERIENCED BLEEDING. THE WOULD CARE NURSE INDICATED THAT THE PATIENT UNDERWENT SURGICAL DEBRIDEMENT PRIOR TO PLACEMENT ON V.A.C. THERAPY. THE WOUND CARE NURSE FURTHER INDICATED THAT 50 CC OF BLOOD WAS NOTED IN THE CANISTER AND V.A.C. THERAPY WAS STOPPED, PRESSURE APPLIED AND THE PHYSICIAN WAS CALLED TO EVALUATE THE WOUND. THE PHYSICIANS NOTE INDICATES THAT THE PATIENT EXPERIENCED A SMALL VESSEL BLEED AND THREE SUTURES WERE APPLIED AT THE BED SIDE UNDER LOCAL ANESTHESIA. ACCORDING TO WOUND CARE NURSE, PATIENT WAS STABLE AND EXPERIENCED NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM JCX KCI USA, INC. VAC ATS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention