BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1083432 · Received July 29, 2008

    Report

    Report Number
    1625774-2008-00031
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 26, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO FROM THE FACILITY IN WHICH THE REPORTED EVENT OCCURRED: 2008 - MGR, SURGICAL SERVICES, 7/1/08 - INITIAL REPORTER IN BIOMEDICAL DEPT, AND 7/2/08, 7/3/08, 7/15/08 AND 7/16/08 RISK MGR. ALL ATTEMPTS TO CONTACT THE FACILITY HAVE BEEN UNSUCCESSFUL IN OBTAINING ANY ADD'L INFO. A KCI REP INDICATED ON 7/2/08 THAT IT WAS REPORTED TO HIM THAT A NURSE WAS TRYING TO REMOVE THE FOAM DURING A DRESSING CHANGE AND COULD NOT, SO THE PT WAS TAKEN TO SURGERY. ACCORDING TO OUR RECORDS, THE PT HAS A SURGICAL, NON-DEHISCED WOUND ON HER LEFT HAND. THE PT HAS BEEN RECEIVING VAC THERAPY AT HOME SINCE 6/27/08 UPON DISCHARGE FROM FACILITY. THIS REPORT IS BEING SUBMITTED SINCE SURGICAL INTERVENTION WAS ALLEGED. DEVICE WAS RETURNED TO KCI QUALITY ENGINEERING FOR EVAL. THE DEVICE MET SPECS. THE DEVICE EVAL ALSO INDICATED THAT THE PRESSURE DURING THERAPY WAS -125MMHG.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHILE A PT WAS IN HOSPITAL, THE AMOUNT OF NEGATIVE PRESSURE USED WAS TOO HIGH AND THE FOAM DRESSING BECAME IMBEDDED IN THE WOUND. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE FOAM. DRESSING FROM THE WOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention