BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C.® THERAPY

    MDR report key: 6179453 · Received December 15, 2016

    Report

    Report Number
    3009897021-2016-00113
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    January 1, 2005
    Report Date
    January 16, 2017
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER (IN CONFIDENCE): ORIGINALLY REPORTED AS: (B)(6). CORRECTION: (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENTS INCLUDED IN THIS STUDY WERE FOLLOWED FROM 2005-2007. IT IS UNKNOWN WHEN THE EVENTS OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE, IT CANNOT BE DETERMINED IF THE ALLEGED WOUND INFECTIONS ARE RELATED TO V.A.C.® THERAPY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, BUT NO ADDITIONAL INFORMATION AS BEEN RECEIVED. DEVICE LABELING, AVAILABLE IN PRINT, 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 PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'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. DRESSING CHANGES WOUNDS BEING TREATED WITH THE V.A.C.® THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. MAINTAINING A SEAL FOR DELICATE PERIWOUND TISSUE OR IN AREAS THAT ARE DIFFICULT TO DRESS, APPLY PROTECTIVE SKIN PREPARATION AND FRAME THE WOUND WITH TRANSPARENT FILM OR HYDROCOLLOID DRESSING OR OTHER APPROPRIATE BARRIER; POSITION THE DRESSING TUBING ON FLAT SURFACES AND AWAY FROM THE PERINEAL AREA, BONY PROMINENCES OR PRESSURE AREAS. DEVICE IDENTIFIER NOT PROVIDED.

    Description of Event or Problem · 1

    ON NOV 16 2016, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER COMPLETING A REVIEW OF JOURNAL ARTICLE ANN-MARI WALLIN, LENNART BOSTROM, JOHANNA ULFVARSON, CARIN OTTOSSON. NEGATIVE PRESSURE WOUND THERAPY - A DESCRIPTIVE STUDY. OSTOMY WOUND MANAGEMENT. 2011; 57(6); 22-29 THAT REPORTED FIVE PATIENTS DEVELOPED INFECTIONS DURING V.A.C.® THERAPY TREATMENT. ON NOV 23 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE CO-AUTHOR: A RELATIONSHIP OF THE INFECTIONS AND THE USE OF V.A.C.® THERAPY TREATMENT COULD NOT BE RULED OUT, BUT THE CO-AUTHOR INDICATED THERE WERE OTHER FACTORS SUCH AS THE PATIENT'S QUALITY OF LIFE ISSUES THAT COULD HAVE CONTRIBUTED AS WELL. THE TYPE OF INTERVENTION REQUIRED WAS NOT PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT TYPE AND SERIAL NUMBER WAS NOT PROVIDED AND IS UNAVAILABLE FOR RETURN, THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827796 V.A.C.® THERAPY OMP OMP KCI USA, INC. UNKVAC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other