BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 3621997 · Received February 5, 2014

    Report

    Report Number
    3621997
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 5, 2014
    Manufacturer
    CAREFUSION 213 LLC
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PREPPING THE GROINS FOR CARDIAC PROCEDURE INJURY TO SKIN ABRASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75974 N/A RAZOR, SURGICAL LWK CAREFUSION 213 LLC CF 27-101 UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR