BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOZORB MARKER

    MDR report key: 6252057 · Received January 13, 2017

    Report

    Report Number
    3009718212-2017-00002
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 19, 2016
    Report Date
    April 19, 2017
    Manufacturer
    FOCAL THERAPEUTICS, INC
    Product Code
    NEU
    PMA / PMN Number
    K143484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS THAT PATIENT PRESENTED WITH PORTION OF DEVICE VISIBLE THROUGH HER ORIGINAL LUMPECTOMY INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34034 BIOZORB MARKER TISSUE MARKER NEU FOCAL THERAPEUTICS, INC F0304 D1-160203

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R