BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICLIP

    MDR report key: 6127146 · Received November 25, 2016

    Report

    Report Number
    6127146
    Event Type
    Malfunction
    Date Received
    November 25, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 12, 2016
    Manufacturer
    CAREFUSION 213 LLC
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT SURGICAL CENTER ASSOCIATE SHAVED THE UNDERARM OF PATIENT FOR SHOULDER SURGERY. DURING THE SHAVE THE PATIENT'S UNDERARM WAS ABRADED. WE STARTED USING THESE NEW CAREFUSION CLIPPER BLADES ABOUT 3 WEEKS AGO AND HAVE HAD NUMEROUS PROBLEMS WITH THESE BLADES. ONE PATIENT'S ABRASIONS WERE RATHER SEVERE. AT THIS POINT, THREE WEEKS AFTER BEGINNING USE OF THE CAREFUSION PRODUCT, APPROXIMATELY 50% OF OUR PATIENTS HAVE EXPERIENCED ABRASIONS OR NICKS FROM THE SHAVING. WE SWITCHED FROM THE BASIC HEAD TO THE PINK SENSI HEAD AND STILL ARE HAVING ISSUES. THE REP CAME IN TO RE-TRAIN AND DISCUSSED USING SOAP AND WATER WHICH IS NOT SOMETHING WE TYPICALLY DO IN SAME DAY SURGERY SETTING. THE BROCHURE STATES TO HOLD THE HEAD FLAT AT THE SURFACE; THIS IS NOT ALWAYS POSSIBLE ON CERTAIN BODY AREAS. WE ARE SEEING ISSUES WITH SHAVING AXILLA FOR SHOULDERS AND GROINS FOR HERNIAS. WE HAVE DISCUSSED CONVERTING BACK TO THE 3M HEAD AND CLIPPER SINCE WE HAVE TRIED 2 DIFFERENT CLIPPER HEADS FROM CAREFUSION AND ARE STILL HAVING ISSUES. WE ARE CONCERNED ABOUT THE POTENTIAL FOR POST OP INFECTION IN ADDITION TO THE HARM TO OUR PATIENTS IN THE FORM OF NICKS AND ABRASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778139 SENSICLIP RAZOR, SURGICAL LWK CAREFUSION 213 LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO