BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURMARK EVIVA SITE IDENTIFICATION SYSTEM

    MDR report key: 1637711 · Received March 10, 2010

    Report

    Report Number
    3003862400-2010-00005
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 10, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K062528
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO DOCTOR THAT THE MARKER TIP WAS STICKING OUT OF HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURMARK EVIVA SITE IDENTIFICATION SYSTEM BIOPSY SITE TISSUE MARKER NEU HOLOGIC, INC. SMARK EVIVA 13 910091

    Patients

    Seq Age Sex Outcome Treatment
    1