BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2010801 · Received March 2, 2011

    Report

    Report Number
    1625774-2011-00026
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    November 17, 2009
    Report Date
    January 31, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K06227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 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 AND CREATE DIFFICULTY IN REMOVING FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. BASED ON INFO PROVIDED BY THE HEALTH CARE PROVIDERS IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C. WHITEFOAM 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

    ON (B)(6) 2011, THE FOLLOWING INFO WAS REPORTED TO KCI BY RECEIVING MEDICAL RECORDS FOR REVIEW: AFTER REVIEWING THE INFO IT WAS IDENTIFIED THAT ON (B)(6) 2009, DURING A SURGICAL PROCEDURE OF AN INCISION AND DRAINAGE OF THE LEFT INFECTED HIP, THE OPERATIVE NOTE STATES THAT THERE WERE TWO FOREIGN MATERIALS FOUND IN THE DEEP PORTION OF THE WOUND. THE FOREIGN MATERIALS WERE REMOVED. ADDITIONAL INFO WAS OBTAINED ON (B)(6) 2011, THE DOCTOR REPORTED THAT ON (B)(6) 2009, THE PT UNDERWENT A SURGICAL PROCEDURE UNDER GENERAL ANESTHESIA TO DEBRIDE THE WOUND AND THE FOREIGN MATERIALS WAS FOUND AND REMOVED. AFTER THE FOREIGN MATERIALS WAS REMOVED THE PT IMPROVED AND THE WOUND HEALED. THE PT WAS DOING WELL.

    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 52 YR Required Intervention