BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA¿ PEEL & PLACE¿ KIT

    MDR report key: 6145745 · Received December 5, 2016

    Report

    Report Number
    3009897021-2016-00103
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED "BRIGHT RED" BLOOD AT THE WOUND SITE WAS RELATED TO THE USE OF THE PREVENA¿ PEEL & PLACE¿ KIT. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: THERAPY SHOULD BE CONTINUOUS FOR A MINIMUM OF 2 DAYS UP TO A MAXIMUM OF 7 DAYS. PATIENTS SHOULD BE INSTRUCTED NOT TO TURN THERAPY OFF UNLESS: ADVISED BY THE TREATING PHYSICIAN. BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING THERAPY. THERE ARE SERIOUS SIGNS OF ALLERGIC REACTION OR INFECTION. THE CANISTER IS FULL OF FLUID. BATTERIES NEED TO BE CHANGED. SYSTEM ALERTS MUST BE ADDRESSED: PATIENT SHOULD BE INSTRUCTED TO CONTACT THE TREATING PHYSICIAN IF: BLEEDING DEVELOPS. SIGNS OF INFECTION ARE PRESENT. THERAPY UNIT TURNS OFF AND CANNOT BE RESTARTED BEFORE THERAPY IS SCHEDULED TO END. INDICATOR AND ALERT SYMBOLS ON THE THERAPY UNIT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE UNIT HAD BEEN ALARMING LEAK AND MAKING NOISE. THERE WAS ALLEGEDLY "BRIGHT RED" BLOOD THAT HAD SEEPED INTO HER DRESSING AND SHE WAS GOING TO THE EMERGENCY ROOM. NO ADDITIONAL INFORMATION IS AVAILABLE. ON (B)(6) 2016, KCI QUALITY ENGINEERING DETERMINED THE FOLLOWING: LOT NUMBER: 2898893. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING PERFORMANCE MET SPECIFICATIONS. ON (B)(6) 2016, KCI QUALITY ENGINEERING DETERMINED THE FOLLOWING: THE UNIT WAS NOT RETURNED. THEREFORE, KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795945 PREVENA¿ PEEL & PLACE¿ KIT OMP OMP KCI USA, INC. WNDPRV 2898893

    Patients

    Seq Age Sex Outcome Treatment
    1 Other