BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3158400 · Received May 29, 2013

    Report

    Report Number
    3158400
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CAREFUSION 213 LLC
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THREE SEPARATE PATIENTS; EACH BEING PREPARED FOR SURGERY WERE NOTED TO HAVE ABRASIONS, REDDENED BUMPS, SCRAPES AND/OR BLEEDING FOLLOWING HAIR REMOVAL WITH CLIPPERS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CLIPPING, PREPPING SURGICAL SITES OF PATIENTS PRIOR TO SURGERY; AN AMPULLARY CARCINOMA, A HIP REPLACEMENT AND THE THIRD WAS A PROSTATE SURGERY. EACH PATIENT HAD SEPARATE CLIPPER HEADS BUT OF SAME LOT NUMBER.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234360 * RAZOR, SURGICAL LWK CAREFUSION 213 LLC CF27-101 280113 280118
    234361 * RAZOR, SURGICAL LWK CAREFUSION 213 LLC CF27-101 280113 280118
    234362 * RAZOR, SURGICAL LWK CAREFUSION 213 LLC CF27-101 280113 280118

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NO OTHER DEVICES BEING USED
    2 59 YR
    3 78 YR