BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C THERAPY SYSTEM

    MDR report key: 2031110 · Received March 22, 2011

    Report

    Report Number
    1625774-2011-00037
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    September 1, 2010
    Report Date
    February 21, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 INFECTON 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 GRANUFOAM 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 REVIEWING MEDICAL DOCUMENTS: ON (B)(6) 2010, THE PROGRESS NOTES STATE THAT THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF THE DECUBITUS ULCER OF THE LEFT BUTTOCK. TOPICAL ANESTHESIA WAS GIVEN WITH 5% XYLOCAINE SOLUTION. DURING THE DEBRIDEMENT, THERE WAS A LARGE DARK FOREIGN-BODY-LIKE MATERIAL FOUND. THE FOREIGN MATERIAL WAS REMOVED FROM THE SUBCUTANEOUS LAYER. IT WAS THEN FOUND THAT THERE WAS A TUNNEL DEEP INTO THE LEFT HIP AREA MEASURING APPROXIMATELY 10.5 CM. A TOTAL OF 3.0CM X 2.0 CM OF MULTIPLE PIECES OF NECROTIC MATERIAL WAS REMOVED AND SOME WITH PURULENCE. TISSUE CULTURES WERE TAKEN BUT NO RESULT WERE DOCUMENTED. ON (B)(6) 2010, THE WOUND WAS CLEAN AND GRANULATING. V.A.C THERAPY CONTINUED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention TEGRETOL: 200 MG 2 TABS 2 A DAY| FORTAZ INTRAVENOUS: 1 GRAM EVERY 8 HOURS| VANCOMYCIN INTRAVENOUS: 1.25GRAMS EVERY 8 HRS| NEURONTIN: 300MG DAILY AND AT BEDTIME