BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENOMARK BREAST BIOPSY MARKER

    MDR report key: 3143042 · Received May 23, 2013

    Report

    Report Number
    2020394-2013-00168
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    NEU
    PMA / PMN Number
    K050090
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A BREAST TISSUE MARKER WAS IMPLANTED, THE PT HAD A REACTION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228053 SENOMARK BREAST BIOPSY MARKER NEU BARD PERIPHERAL VASCULAR, INC. VT12G0849

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening