BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3093831 · Received April 30, 2013

    Report

    Report Number
    3009897021-2013-00038
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODIES ALLEGED TO BE GRANUFOAM DRESSING WERE 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 ADD'L INFO, 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE HOME HEALTH NURSE REPORTED OBSERVING SMALL PIECES OF A FOREIGN MATERIAL ALLEGED TO BE V.A.C. GRANUFOAM DRESSING ADHERING TO THE WOUND. THE PATIENT INFORMED THE NURSE THAT THE PHYSICIAN WAS PLANNING TO "DEBRIDE THEM OUT," BUT HAS YET TO REMOVE THE FOREIGN MATERIAL. ON (B)(6) 2013, THE FOLLOWING INFO WAS REPORTED TO KCI BY THE WOUND CARE NURSE: THE WOUND HAS NOT BEEN DEBRIDED AT THIS TIME. THE PATIENT NEEDS TO SCHEDULE AN APPOINTMENT IN ORDER FOR THE PHYSICIAN TO PERFORM THE DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186398 V.A.C. THERAPY OMP KCI USA INC. GRANUFOAM DRESSING

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention