BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORAD

    MDR report key: 2913002 · Received January 3, 2013

    Report

    Report Number
    2913002
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 3, 2013
    Manufacturer
    HOLOGIC
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    BURNING SMELL NOTED ALONG WITH SMOKE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4315 LORAD TABLE KXJ HOLOGIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR