BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3223768 · Received July 10, 2013

    Report

    Report Number
    3009897021-2013-00067
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    February 24, 2012
    Report Date
    June 20, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE ALLEGED THAT THE FOREIGN MATERIAL ALLEGED TO BE V.A.C. WHITE-FOAM DRESSING CONTRIBUTED TO THE PT'S DEVELOPMENT OF AN ABSCESS AND OSTEOMYELITIS. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C WHITE-FOAM DRESSING WAS INADVERTENTLY LEFT IN THE WOUND. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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 PIECES OF FOAM WERE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT STATED THAT SHE HAS BEEN OFF V.A.C. THERAPY "FOR AWHILE" AND ON A DATED NOT PROVIDED, ALLEGED DEVELOPING A 23CM ABSCESS AND OSTEOMYELITIS DUE TO RETAINED FOREIGN MATERIAL ALLEGED TO BE V.A.C. WHITE-FOAM DRESSING. THE PT INQUIRED IF V.A.C. FOAM IS DETECTABLE ON X-RAY BECAUSE SHE WANTED TO ENSURE THAT ALL OF THE FOREIGN MATERIAL HAD BEEN REMOVED. ON (B)(6) 2013, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2012, UPON PERFORMING AN INCISION AND DRAINAGE OF AN ABSCESS, A FOREIGN MATERIAL WAS DISCOVERED, AND SHARP DEBRIDEMENT WAS REQUIRED FOR REMOVAL. THE NURSE STATED THE PT DEVELOPED OSTEOMYELITIS BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315053 V.A.C. THERAPY OMP KCI USA INC. V.A.C. WHITEFOAM

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention