BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1241079 · Received November 20, 2008

    Report

    Report Number
    1625774-2008-00056
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO DEVICE MALFUNCTION WAS REPORTED OR IMPLIED, THE ALLEGED ADVERSE EVENT IS BEING REPORTED IN ACCORDANCE WITH INTERNAL COMPANY PROCEDURES. V.A.C. LABELING WARNS, "EXCESS TUBING MAY PRESENT A TRIPPING HAZARD; ENSURE THAT EXCESS TUBING IS STORED IN THE TUBING POCKET AND IS OUT OF AREAS WHERE PEOPLE MAY WALK."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS BEING TREATED WITH V.A.C. THERAPY FOR AN ABSCESS TO HER RIGHT LOWER ABDOMINAL AREA, TRIPPED OVER THE V.A.C. THERAPY TUBING AND ALLEGEDLY FRACTURED HER RIGHT ANKLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention CELLCEPT| HYDROLOZINE| CONADINE| NOVOLIN N| PREDNISONE| PROGRAS| FERROUS| BALCYTE| SULFATE| LABETALOL| NORVASC| NOVOLIN R| SODIUM BICARBONATE