BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM

    MDR report key: 2093866 · Received April 22, 2011

    Report

    Report Number
    3003862400-2011-00002
    Event Type
    Other
    Date Received
    April 22, 2011
    Report Date
    April 21, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K072913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT (B)(6) MONTH F/U, PT PRESENTED WITH A POSSIBLE MASS AT THE BIOPSY SITE. AFTER BIOPSYING AGAIN, IT WAS INFLAMMATORY RESPONSE WHICH PHYSICIAN BELIEVES MAY BE RELATED TO THE BIOPSY SITE MARKER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1