BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1321802 · Received February 20, 2009

    Report

    Report Number
    1625774-2009-00018
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 21, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOME HEALTH AGENCY NURSE (RN) STATED THAT V.A.C. GRANUFOAM WAS ORIGINALLY USED ON THE PATIENT'S WOUND, BUT WAS SWITCHED TO V.A.C. WHITEFOAM IN 2008. ACCORDING TO THE RN, THE PATIENT INITIALLY RESPONDED WELL TO V.A.C. WHITEFOAM, BUT IN 2009, THE PATIENT WAS REPORTED TO HAVE HAD AN ELEVATED TEMPERATURE AND BLOOD SUGAR LEVEL. THE RN STATED THAT V.A.C. THERAPY WAS SUBSEQUENTLY DISCONTINUED AND THE PATIENT WAS SWITCHED TO AN ALTERNATIVE DRESSING. ACCORDING TO THE RN, THE PATIENT WAS SEEN BY THE PRESCRIBING PHYSICIAN AT ABOUT ONE WEEK LATER, AND AN ANTIBIOTIC THERAPY TREATMENT WAS STARTED. THE RN ALSO STATED THAT THE PATIENT HAD POOR CONTROL OVER HER BLOOD SUGAR LEVELS, WHICH PUT HER AT RISK FOR DEVELOPING AN INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVING V.A.C. THERAPY FOR AN ABDOMINAL SURGICAL WOUND WAS GIVEN ANTIBIOTICS FOR TREATMENT OF AN INFECTION. ON 02/09/2009, THE HOME HEALTH AGENCY NURSE (RN) REPORTED THAT THE INFECTION HAD RESOLVED. THE RN ALSO STATED THAT THE WOUND STARTED TO IMPROVE SHORTLY, AFTER ADMINISTERING ANTIBIOTICS TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention