BEUDAMED
    FDA Adverse Event Other Summary report: N

    V.A.C. (VACUUM ASSISTED CLOSURE)

    MDR report key: 413700 · Received August 26, 2002

    Report

    Report Number
    MW1025997
    Event Type
    Other
    Date Received
    August 26, 2002
    Date of Event
    July 25, 2002
    Report Date
    August 23, 2002
    Manufacturer
    KCI
    Product Code
    GCY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE FOR POSTOP WOUND INFECTION IDENTIFIED AS BLACK KCI WOUND V.A.C. SPONGE THAT HAD BEEN RETAINED FOR AN UNDETERMINED PERIOD OF TIME.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 11-22-02: IN THE COURSE OF THE INVESTIGATION, KCI REVIEWED THE PT'S V.A.C. PLACEMENT HISTORY AND DETERMINED THE PT RECEIVED V.A.C. THERAPY FROM MARCH 2002 THROUGH APRIL 2002 AT WHICH TIME THE V.A.C. SYSTEM WAS DISCONTINUED AND THE PT WAS DISCHARGED TO AN EXTENDED CARE FACILITY. IT IS ESTIMATED THAT THE PT WAS READMITTED TO THE REPORTING FACILITY SOMETIME IN MID-JUNE. IN THE REPORTED INCIDENT, ONE OF THE PIECES THAT HAD BEEN INSERTED FOR V.A.C. THERAPY HAD REPORTEDLY NOT BEEN REMOVED WHEN THERAPY WAS DISCONTINUED. ALL MEDICAL PROFESSIONALS ARE AWARE OF THE BASIC MEDICAL STANDARD OF CARE GUIDELINES. THE GUIDELINES INCLUDE PRECAUTIONS TO COUNT AND RECORD THE NUMBER OF PIECES INSERTED IN A WOUND AND/OR BODY CAVITY AND TO ACCOUNT FOR EACH PIECE WHEN REMOVED. THE KCI CORPORATE REP INVESTIGATING THE MATTER HAS ASKED THE FACILITY PERSONNEL FOR MORE INFO TO FACILITATE KCI'S INVESTIGATION. HOWEVER, SUCH PERSONNEL AT THE FACILITY HAVE NOT BEEN WILLING TO PROVIDE ANY ADD'L INFO AT THIS TIME. THE BLACK POLYURETHANE FOAM DRESSING IS COMPOSED OF A POLYURETHANE MATERIAL, PACKAGED STERILE FOR SINGLE USE ONLY AND AVAILABLE IN SMALL, MEDIUM AND LARGE SIZES. THERE IS NO EVIDENCE OR INFO THAT SUGGESTS THE FOAM DRESSING INTRODUCED THE INFECTION INVOLVED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. (VACUUM ASSISTED CLOSURE) WOUND CLOSURE GCY KCI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other