BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKER BIOZORB 2X2CM

    MDR report key: 19529343 · Received June 12, 2024

    Report

    Report Number
    MW5156228
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    January 10, 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 1. NEEDLE-LOCALIZED LUMPECTOMY, LEFT BREAST CANCER, BIOZORB PLACEMENT LEFT, LEFT SENTINEL LYMPH NODE BIOPSY, LEFT BREAST BIOPSY FOR PRIOR FINDING OF PAPILLOMA, RIGHT NEEDLE-LOCALIZED LUMPECTOMY, RIGHT BIOZORB PLACEMENT, RIGHT SENTINEL LYMPH NODE BIOPSY. (B)(6) 2022 - THERE IS A LITTLE BIT OF ERYTHEMA ON THE RIGHT LATERAL BREAST BUT NO WARMTH OR TENDERNESS. NO PERCEIVED INFECTION. (B)(6) 2022 - CONCERN FOR POSSIBLE MASTITIS, PATIENT HAD BEEN TREATED WITH 7-DAY COURSE OF BACTRIM. ULTRASOUND COMPLETE (B)(6) 2022 WITH NO SUSPICIOUS FINDINGS. ADDITIONAL BIOZORB IMPLANT INFORMATION. IMPLANTED: (B)(6) 2022. MODEL: F0203. LOT: # 21DOSRG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190110 MARKER BIOZORB 2X2CM MARKER, RADIOGRAPHIC, IMPLANTABLE NEU FOCAL THERAPEUTICS / HOLOGIC, INC. F0202 21F17RJ

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other