BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1301120 · Received January 30, 2009

    Report

    Report Number
    1625774-2009-00014
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICAL THERAPIST CARING FOR THE PT STATED THAT SHE DID NOT BELIEVE THAT V.A.C. THERAPY PLAYED A ROLE IN THE ALLEGED EVENT. ACCORDING TO THE PHYSICAL THERAPIST, THE PT WAS NON-COMPLIANT WITH THERAPY. THE REPRESENTATIVE STATED THAT THE PT WOULD REMOVE THE V.A.C. DRESSING ON THEIR OWN AND NOT COMMUNICATE TO HIS CAREGIVERS THE NUMBER OF FOAM PIECES THAT WERE REMOVED. THIS APPEARS TO BE A CASE OF USE ERROR (PT NON-COMPLIANCE), WHERE THE FOAM WAS LEFT IN THE PT'S WOUND WHICH RESULTED IN THE FOAM BEING SURGICALLY REMOVED. V.A.C. LABELING WARNS UNDER "FOAM PLACEMENT": "DO NOT PLACE ANY FOAM DRESSING UNTO BLIND/UNEXPLORED TUNNELS. THE V.A.C. WHITEFOAM DRESSING MAY BE MORE APPROPRIATE FOR USE WITH EXPLORED TUNNELS. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM USED IN THE WOUND AND DOCUMENT THAT NUMBER ON THE DRAPE AND IN THE PT'S CHART." IT ALSO STATES UNDER "FOAM REMOVAL": 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 THE FOAM FROM THE WOUND, OR LEAD OF INFECTION OR OTHER ADVERSE EVENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT RECEIVING V.A.C. THERAPY FOR BILATERAL ISCHIAL PRESSURE ULCERS REQUIRED TWO SURGERIES FOR REMOVAL OF PIECES OF V.A.C. GRANUFOAM DRESSING THAT WERE INADVERTENTLY LEFT IN A TUNNEL OF THE PT'S WOUND. ACCORDING TO THE PHYSICAL THERAPIST CARING FOR THE PT, A PIECE OF V.A.C. GRANUFOAM WAS REMOVED BY SHARP DEBRIDEMENT DURING A SURGICAL PROCEDURE THAT WAS PERFORMED IN 2008. THE PHYSICAL THERAPIST STATED THAT V.A.C. THERAPY WAS THEN REAPPLIED. DURING THE PT'S NEXT VISIT THE FOLLOWING MONTH, ANOTHER PIECE OF FOAM, BELIEVED TO HAVE BEEN RETAINED FROM THE ORIGINAL EPISODE, WAS FOUND IN THE PT'S WOUND. THE PIECE OF FOAM WAS AGAIN REMOVED BY SHARP DEBRIDEMENT AND V.A.C. THERAPY WAS REAPPLIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention