BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAZOR, SURGICAL

    MDR report key: 6137821 · Received December 1, 2016

    Report

    Report Number
    6137821
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 5, 2016
    Manufacturer
    CAREFUSION 213 LLC
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY BEGAN USING CARE FUSION'S SURGICAL CLIPPER WITH DISPOSABLE HEAD (SENSITIVE HEAD) THIS YEAR. ASSOCIATES IN SAME DAY SURGERY HAVE REPORTED SEVERAL INSTANCES IN WHICH PATIENT RECEIVED NICKS AND SCRAPES WHEN USING THIS PRODUCT. THESE ARE DRY SHAVING CLIPPERS AND THE SKIN ABRASIONS AT TIMES HAVE LOOKED LIKE A RAZOR BURN. THESE SKIN ISSUES DID NOT HAPPEN WITH THE PRODUCT PREVIOUSLY USED (BEFORE CAREFUSION). OUR HOSPITAL IS ATTEMPTING TO TRACK ALL OCCURRENCES. ASSOCIATES HAVE RECEIVED TRAINING FROM CAREFUSION REPRESENTATIVES. WE ARE COGNIZANT THAT THIS COULD BE THOUGHT TO BE USER TECHNIQUE, AT TIMES OR IN PART. AGAIN, THE VENDOR HAS BEEN ASKED TO DO DEMOS AND HAS DONE SO. OUR HOSPITAL RECEIVED THE FOLLOWING COMMUNICATION FROM ANOTHER FACILITY ABOUT 2.5 MONTHS AGO: WE ARE WONDERING IF ANY OF YOUR FACILITIES ARE EXPERIENCING PROBLEMS WITH THE USE OF THE CAREFUSION SURGICAL CLIPPERS. WE HAVE AT LEAST 6 REPORTED PATIENT INJURIES (NICKS, CUTS, ETC.). WE CONTACTED OUR LOCAL RESOURCE GROUP REPRESENTATIVE. THE COMPANY SENT OUT SOME FOLKS TO RETRAIN (EDUCATE) OUR STAFF. THEY EVEN STARTED USING THE "SENSITIVE" HEAD AND THE CUTS ARE STILL OCCURRING. MANUFACTURER RESPONSE FOR SURGICAL CLIPPERS, DISPOSABLE HEAD, SENSITIVE HEAD (PER SITE REPORTER): THE REP HAS PROVIDED ADDITIONAL TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788413 RAZOR, SURGICAL LWK CAREFUSION 213 LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO| NO OTHER THERAPIES