BEUDAMED
    FDA Adverse Event Other Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 752026 · Received August 16, 2006

    Report

    Report Number
    1625774-2006-00040
    Event Type
    Other
    Date Received
    August 16, 2006
    Date of Event
    July 17, 2006
    Report Date
    July 17, 2006
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K032310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE HEALTH CARE PROVIDER (PHYSICIAN'S ASSISTANT) INDICATES THAT THE PATIENT WAS DOING WELL. V.A.C. THERAPY LABELING STATES: "COUNT THE PIECES OF FOAM AND ANNOTATE THE TOTAL NUMBER IN THE PATIENT'S CHART. ALSO ANNOTATE ON DRAPE WITH PERMANENT MARKER. DO NOT PLACE FOAM INTO BLIND OR UNEXPLORED TUNNELS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY TWO YEARS AGO ON HIS LOWER BACK AND HAD SUBSEQUENT INFECTIONS REQUIRED V.A.C. THERAPY. THE PATIENT HAD UP TO EIGHT SUBSEQUENT SURGERIES. THE PATIENT RETURNED TO SURGERY, IN 2006, DUE TO STENOSIS ABOVE THE PREVIOUS SPINAL FUSION SITE. IT WAS DISCOVERED THAT THE V.A.C. DRESSING HAD ADHERED TO THE DURA OF THE SPINAL CORD. THE DOCTOR THINNED DOWN THE AREA OF THE FOAM TO DECREASE THE RISK OF INFECTION. HE WAS UNABLE TO REMOVE ALL OF THE FOAM BECAUSE OF THE RISK OF OPENING THE DURA. THE PHYSICIAN ALSO MADE THE DECISION TO NOT PLACE SPINAL HARDWARE DUE TO THE RISK OF INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention