BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 5454019 · Received February 23, 2016

    Report

    Report Number
    3009897021-2016-00017
    Event Type
    Injury
    Date Received
    February 23, 2016
    Date of Event
    January 25, 2016
    Report Date
    February 23, 2016
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FUNGAL INFECTION IS RELATED TO V.A.C. THERAPY. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE NURSE ALLEGEDLY OBSERVED A FOUL ODOR FROM THE PATIENT'S WOUND. ON (B)(6) 2016, KCI GLOBAL SAFETY REPRESENTATIVE SPOKE TO THE PATIENT'S CAREGIVER WHO REPORTED THE PATIENT HAS HAD A PRIOR INFECTION IN THE WOUND. ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT'S DISTAL WOUND HAS A YEAST INFECTION. THE PATIENT IS CURRENTLY ON A WET TO DRY DRESSING REGIMEN PENDING PHYSICIAN'S ORDERS FOR DIFLUCAN, AN ANTIFUNGAL MEDICATION. ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT RECEIVED AN ANTIFUNGAL MEDICINE FOR THE YEAST INFECTION WHICH HAS RESOLVED. ON (B)(6) 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2016, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111182 ACTIV.A.C.® THERAPY OMP OMP KCI USA,INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention WARFARIN 5MG DAILY