BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOZORB MARKER

    MDR report key: 6001607 · Received October 5, 2016

    Report

    Report Number
    3009718212-2016-00001
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 28, 2016
    Manufacturer
    FOCAL THERAPEUTICS, INC
    Product Code
    NEU
    PMA / PMN Number
    K143484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED (B)(6) 2016 FOR INVESTIGATION AND THE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT PATIENT PRESENTED WITH PORTION OF DEVICE VISIBLE WITHIN HER ORIGINAL LUMPECTOMY INCISION APPROXIMATELY 10 MONTHS AFTER SURGERY AND RADIATION TREATMENT FOR BREAST CANCER. PATIENT WAS TAKEN TO SURGERY THE FOLLOWING DAY TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650761 BIOZORB MARKER TISSUE MARKER NEU FOCAL THERAPEUTICS, INC F0203 B2-150601

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R