BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOTECH

    MDR report key: 3084838 · Received April 23, 2013

    Report

    Report Number
    MW5029947
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    GDM
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) FEMALE UNDERWENT NEEDLE LOCALIZATION WIDE EXCISION LUMPECTOMY OF RIGHT BREAST ON (B)(6) 2013. ON FOLLOW UP VISIT TO RADIATION ONCOLOGY, WAS GIVEN A COPY OF CT AND TOLD OF THE NEED TO FOLLOW UP WITH SURGEON FOR SOMETHING THAT WAS SEEN ON CT FILM DONE IN PREP FOR RADIATION. SEEN (B)(6) 2013 BY SURGEON WITH FINDING OF A PIECE OF WIRE FELT TO BE FROM THE NEEDLE LOCALIZATION. WIRE REMOVED UNDER LOCAL IN OFFICE. FOLLOW UP X-RAY WITH NO EVIDENCE OF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174536 ANGIOTECH HAWKINS III HARDWIRE BLN GDM MEDICAL DEVICE TECHNOLOGIES, INC. UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention