BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2041999 · Received March 31, 2011

    Report

    Report Number
    1625774-2011-00043
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 2, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES VAC FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF PIECES OF FOAM REMOVED AS PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER IN-GROWTH OF TISSUE INTO THE FOAM AND CREATE DIFFICULTY IN REMOVING FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. BASED ON INFORMATION PROVIDED BY THE HEALTH CARE PROVIDERS IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C. WHITEFOAM DRESSING WAS INADVERTENTLY LEFT IN THE WOUND. THE FOREIGN BODY WAS NOT RETURNED TO KCI FOR IDENTIFICATION THEREFORE KCI WAS UNABLE TO CONFIRM IDENTITY OF THE FOREIGN OBJECT. THERE WAS NO PRODUCT MALFUNCTION. THIS REPORT IS BEING FILED DUE TO USER MISUSE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: ON AN UNKNOWN DATE THE PATIENT UNDERWENT SURGERY FOR A HUMERUS FRACTURE AND AN INFECTED ELBOW. THE PATIENT HAD A TUNNELING UNDER THE SUTURE LINE. THE NURSE PLACED V.A.C. WHITEFOAM DRESSING UNDER THE SUTURE LINE TO FILL IN THE DEAD SPACE BUT WHEN THE WARD NURSE WAS TO CHANGE THE DRESSING THE NURSE DID NOT SEE THE V.A.C. WHITEFOAM DRESSING AND ONLY DID THE DRESSING CHANGE ON THE ELBOW WOUND. ON (B)(6) 2011, DURING EXPLORATION OF THE WOUND THE PHYSICIAN FOUND FOREIGN MATERIAL UNDER THE SUTURE LINE. PHYSICIAN REPORTED THAT THE NURSE APPARENTLY NEGLECTED TO REMOVE THE FOREIGN MATERIAL DURING SUBSEQUENT DRESSING CHANGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention