BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKER BIOZORB 2X2CM F0202

    MDR report key: 19529658 · Received June 12, 2024

    Report

    Report Number
    MW5156232
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    February 4, 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

    ON (B)(6) 2022 - PATIENT UNDERWENT NEEDLE LOCALIZED LUMPECTOMY, BIOZORB PLACEMENT AND SENTINEL LYMPH NODE BIOPSY, RIGHT; (B)(6) 2022 -PATIENT REPORTS SWELLING TO R AXILLA. ON (B)(6) 2022 - R AXILLE SWELLING HAS INCREASED PER PATIENT AND HAVING DISCOMFORT IN THAT AREA. SEROMA PRESENT. ASPIRATED 60CC OF CLEAR YELLOW SEROUS FLUID; (B)(6) 2022 - PER PATIENT FLUID COLLECTION HAS RETURNED. ON (B)(6) 2022 - SEROMA DRAINED AGAIN - 66CC OF FLUID REMOVED. FLUID CLEAR AND YELLOW NO ODOR OF EVIDENCE OF INFECTION (B)(6) 2022 - ULTRASOUND GUIDED ASPIRATION OF SEROMA 120ML OF FLUID REMOVED. ON (B)(6) 2022 - SEROMA BACK THIS TIME AREA WARM AND RED. DRAINED, CULTURED AND ANTIBIOTIC STARTED; (B)(6) 2022 - PATIENT REPORTS SEROMA ONLY HAS SMALL AMOUNT OF FLUID. COMPLETE ANTIBIOTICS, FEELING BETTER AND WILL BE STARTING RADIATION SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190114 MARKER BIOZORB 2X2CM F0202 MARKER, RADIOGRAPHIC, IMPLANTABLE NEU FOCAL THERAPEUTICS / HOLOGIC INC. F0202 21F17RJ

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other