BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION SURGICAL CLIPPER

    MDR report key: 6050967 · Received October 24, 2016

    Report

    Report Number
    6050967
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    July 5, 2016
    Report Date
    October 7, 2016
    Manufacturer
    CAREFUSION 213, LLC
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRE-OPERATIVE, A PATIENT'S ABDOMEN HAIR WAS TRIMMED WITH SURGICAL CLIPPERS. DURING TRIMMING, SCRATCHES WERE NOTICED TO APPEAR AS A RESULT OF THE SURGICAL CLIPPERS. TRIMMING STOPPED. UPON INSPECTION, THE DISPOSABLE CLIPPER BLADE WAS FOUND TO HAVE MISSING TEETH CREATING A JAGGED SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701667 CAREFUSION SURGICAL CLIPPER RAZOR, SURGICAL LWK CAREFUSION 213, LLC 1015

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other NO OTHER THERAPIES