BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENOMARK BREAST BIOPSY MARKER

    MDR report key: 3170557 · Received May 28, 2013

    Report

    Report Number
    2020394-2013-00173
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    NEU
    PMA / PMN Number
    K050090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COUPLE OF DAYS AFTER A STEREOTACTIC BREAST BIOPSY HAD BEEN PERFORMED AND A BREAST TISSUE MARKER WAS IMPLANTED, THE PT PRESENTED WITH PAIN AND EDEMA AT THE SITE OF THE BIOPSY. ANTIBIOTIC TREATMENT WAS PRESCRIBED. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233086 SENOMARK BREAST BIOPSY MARKER NEU BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ENCOR BIOPSY PROBE