BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKER BIOZORB 3X4CM

    MDR report key: 19529655 · Received June 12, 2024

    Report

    Report Number
    MW5156229
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    July 7, 2022
    Report Date
    June 10, 2024
    Manufacturer
    FOCAL THERAPEUTICS / HOLOGIC, INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2022 - PATIENT UNDERWENT RE-EXCISION FOR MARGINS & BIOZORB PLACEMENT. (B)(6) 2022 - PATIENT NOTED TO HAVE SIGNIFICANT HEMATOMA. (B)(6) 2022 - ULTRASOUND GUIDED ASPIRATION OF HEMATOMA DONE. (B)(6) 2022 ADDITIONAL ULTRASOUND GUIDED ASPIRATION OF HEMATOMA DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190111 MARKER BIOZORB 3X4CM MARKER, RADIOGRAPHIC, IMPLANTABLE NEU FOCAL THERAPEUTICS / HOLOGIC, INC. F0304 D1-201012

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other