BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION SURGICAL CLIPPER

    MDR report key: 3220898 · Received June 26, 2013

    Report

    Report Number
    3220898
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING PREPARED FOR RADICAL PROSTATECTOMY; WHILE LIGHTLY CLIPPING PATIENT'S GROIN AREA FOR SURGERY, THE CLIPPER SCRAPED PATIENT'S LEFT SIDE AND CAUSED IT TO BLEED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CLIPPING HAIR FROM SURGERY SITE PRIOR TO PROSTATECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289494 CAREFUSION SURGICAL CLIPPER RAZOR, SURGICAL LWK CAREFUSION 2200, INC. * *
    289646 CAREFUSION SURGICAL CLIPPER RAZOR, SURGICAL LWK CAREFUSION 2200, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR