BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2982366 · Received February 25, 2013

    Report

    Report Number
    3009897021-2012-00012
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE PT UNDERWENT SURGICAL DEBRIDEMENT OF THE WOUND AND V.A.C. THERAPY WAS INITIATED. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THERE WAS NO ALLEGED PRODUCT MALFUNCTION. 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 INGROWTH 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'S SISTER REPORTED THAT UPON CHANGING THE DRESSINGS, THE NURSE OBSERVED FOREIGN MATERIAL ALLEGED TO BE V.A.C AT GRANUFOAM STAPLED INTO THE WOUND. THE NURSE WAS UNABLE TO REMOVE ONE PIECE OF THE FOREIGN MATERIAL FROM A SMALL "CAVITY". ON (B)(6) 2013, THE FOREIGN MATERIAL WAS SURGICALLY REMOVED. THE PT CONTINUED TO RECEIVE V.A.C. THERAPY AND IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79392 V.A.C. THERAPY OMP KCI USA INC. V.A.C. GRANUFORM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention