BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 4908283 · Received July 9, 2015

    Report

    Report Number
    3009897021-2015-00053
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK WHEN THE EVENT OCCURRED AS THIS INFO HAS NOT BEEN PROVIDED. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION WAS RELATED TO V.A.C. THERAPY. KCI HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFO WITHOUT SUCCESS. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS AND INSTILLATION THERAPY PARAMETERS (FOR THE V.A.C. INSTILL THERAPY SYSTEM). REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C. DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C. THERAPY SHOULD BE DISCONTINUED.

    Description of Event or Problem · 1

    KCI RECEIVED ARTICLE SUBHAS GUPTA, ALLEN GABRIEL, JOHN LANTIS, LUC TEOT. CLINICAL RECOMMENDATIONS AND PRACTICAL GUIDE FOR NEGATIVE PRESSURE WOUND THERAPY WITH INSTILLATION. INTERNATIONAL WOUND JOURNAL 2015; DOI: 10.1111/IVJ.12452 THAT REPORTED A (B)(6) MALE PRESENTED WITH A LARGE INFECTED PLANTAR AND LATERAL MALLEOLAR ULCER WITH EXPOSING STRUCTURES. DURING INITIAL TREATMENT, THE WOUND WAS DEBRIDED AND STANDARD NPWT (NEGATIVE PRESSURE WOUND THERAPY) WAS APPLIED FOR 3 WEEKS. A DERMAL A DERMAL SUBSTITUTE WAS APPLIED, FOLLOWED BY TWO WEEKS SPLIT THICKNESS SURGICAL GRAFT (STSG). TWO WEEKS POST STSG AN INFECTION DEVELOPED. THE PT RETURNED TO THE OPERATING ROOM FOR A SECOND DEBRIDEMENT, FOLLOWED BY INITIATION OF NPWT WITH INSTALLATION. NO ADDITIONAL INFO IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445581 V.A.C. THERAPY OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention