BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1583426 · Received January 21, 2010

    Report

    Report Number
    1625774-2010-00005
    Event Type
    Injury
    Date Received
    January 21, 2010
    Report Date
    December 22, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT TO THE REPORTED EVENT, THE V.A.C. THERAPY UNIT WAS RETURNED TO KCI QUALITY ENGINEERING FOR EVALUATION. EVALUATION OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF A PRODUCT MALFUNCTION OR DEFECT. THE UNIT MET SPECIFICATIONS. THE UNIT WAS ALSO TESTED PER QUALITY CONTROL PROCEDURES AND MET SPECIFICATIONS AFTER THE PT WAS DISCHARGED IN 2009. KCI IS FILING THIS REPORT DUE TO POSSIBLE USE ERROR AS THE V.A.C. GRANUFOAM DRESSING MAY HAVE BEEN LEFT INSIDE THE WOUND BY THE HEALTHCARE PROVIDER FOR A PERIOD LONGER THAN THE TIME RECOMMENDED IN THE V.A.C. THERAPY LABELING AND HAD TO BE SURGICALLY REMOVED. V.A.C. LABELING WARNS, "V.A.C. FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES WAS REMOVED AS PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER IN GROWTH OF TISSUE INTO THE FOAM, CREATE DIFFICULTY IN REMOVING FOAM FROM THE WOUND, OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT REQUIRED SURGICAL INTERVENTION TO REMOVE ADHERED FOAM. IT WAS ALSO REPORTED THAT PIECES OF THE V.A.C. GRANUFOAM WERE LEFT IN THE WOUND. THE PT'S FAMILY MEMBER IS ALLEGING THAT THE INCIDENT MAY HAVE CONTRIBUTED TO POSSIBLE INFECTION. AS OF THIS REPORT, THE PT'S CONDITION, EXISTENCE OF AN INFECTION, SOURCE OF ANY INFECTION AND WHEN IT MANIFESTED COULD NOT BE VERIFIED WITH THE PT'S HEALTH CARE PROVIDERS. THE PT RECEIVED V.A.C. THERAPY IN 2009 IN THE ACUTE CARE SETTING AND CONTINUED UNTIL THE FOLLOWING MONTH, IN THE HOME CARE SETTING. MULTIPLE ATTEMPTS TO CONFIRM THE REPORTED INFO FROM THE MEDICAL PERSONNEL RESPONSIBLE FOR PLACEMENT AND REMOVAL OF THE DRESSINGS HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM ACCESSORY TO OMP OMP KCI USA, INC. V.A.C. GRANUFOAM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASKU