BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1211046 · Received October 24, 2008

    Report

    Report Number
    1625774-2008-00048
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PATIENT'S PHYSICIAN, THE INITIAL OPERATION WHICH RESULTED IN THE PATIENT'S WOUND WAS PERFORMED, AND THE PATIENT WAS SENT HOME TO ANOTHER STATE TO RECUPERATE. THE PATIENT'S PHYSICIAN STATED THAT V.A.C. THERAPY DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT. THE PATIENT'S PHYSICIAN INDICATED THAT THERE WAS A BREAK DOWN IN COMMUNICATION BETWEEN CLINICIANS CARING FOR THIS PATIENT. V.A.C. LABELING STATES "IN A MONITORED NON-INFECTED WOUND, V.A.C. DRESSINGS SHOULD BE CHANGED EVERY 48 TO 72 HOURS, BUT NO LESS THAN THREE TIMES PER WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE."

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CONSULTANT'S PRESENTATION THAT APPROXIMATELY 5-7 YEARS AGO, A PATIENT IN HIS MID-30S WAS PLACED ON V.A.C. THERAPY FOR A SURGICAL RIGHT HIP WOUND. ACCORDING TO THE PATIENT'S PHYSICIAN, THE CLINICIAN IN CHARGE OF PATIENT'S WOUND CARE INTERPRETED THE V.A.C. GRANUFOAM TO BE ESCHAR AND DID NOT REMOVE THE FOAM OVER A SIX WEEK PERIOD OF TIME. DURING THE SIX WEEK POST OPERATIVE VISIT, THE FOAM WAS DISCOVERED BY VISUAL EXAMINATION AND HAD TO BE SURGICALLY REMOVED UNDER GENERAL ANESTHESIA AS AN OUTPATIENT SURGERY. ACCORDING TO THE PATIENT'S PHYSICIAN, THERE WERE NO CLINICAL COMPLICATIONS AS A RESULT OF THE FOAM IN THE WOUND. THE PATIENT'S PHYSICIAN STATED THAT PATIENT RECOVERED FROM THE SURGICAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention