BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKER BIOZORB 2X2CM

    MDR report key: 19510746 · Received June 10, 2024

    Report

    Report Number
    MW5156090
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    March 16, 2023
    Report Date
    June 6, 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

    ON (B)(6) 2023 PT UNDERWENT NEEDLE LOCALIZED LUMPECTOMY, BIOZORB PLACEMENT AND RIGHT SENTINEL LYMPH NODE BIOPSY. ON (B)(6) 2023 PT COMPLAINED OF PAIN AND SWELLING. HEMATOMA NOTED NO SIGNS OF INFECTION. PT UNDERWENT EVACUATION OF HEMATOMA AND REPLACEMENT OF BIOZORB DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189510 MARKER BIOZORB 2X2CM MARKER, RADIOGRAPHIC, IMPLANTABLE NEU FOCAL THERAPEUTICS / HOLOGIC, INC. F0202 22F16RV

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other