BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLOGIC BIOZORB

    MDR report key: 20323194 · Received September 26, 2024

    Report

    Report Number
    MW5160203
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 23, 2024
    Manufacturer
    HOLOGIC SURGICAL PRODUCTS COSTA RICA, SRL
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HOLOGIC BIOZORB MARKER IMPLANTED ON (B)(6) 2024 DURING LUMPECTOMY. ADVERSE REACTIONS NOTICED IN BREAST STARTING ABOUT (B)(6) 2024 (SWELLING, HARDENING OF BREAST, PAIN, DISCOMFORT, SKIN STRETCHING, ETC.). DR. VISIT AT (B)(6) HOSPITAL SUGGESTED FOLLOW UP MAMMOGRAM AND ULTRASOUND. WHICH CONFIRMED IMPLICATION OF THE BIOZORB MARKER. ON EVENING OF PHYSICAL EXAM, A LETTER FROM (B)(6) HEALTH AND HOLOGIC WITH NOTIFICATION THAT THE BIOZORB MARKER COULD HAVE THOSE POSSIBLE SIDE EFFECTS. IN FOLLOW UP ANALYSIS IT WAS FOUND THAT THE BIOZORB MARKER HAD BEEN RECALLED EARLY IN 2024 BY THE FDA (CLASS 1) AND IN (B)(6) OF 2024 DIRECTIVES FOR PROVIDERS TO FOLLOW UP WITH PATIENTS TO MONITOR WITH PATIENTS (NOTHING WAS DONE IN THIS AREA. TILL THE (B)(6) HEALTH LETTER DATED (B)(6) 2024). RESULTS OF MAMMO AND US CONFIRMED BIOZORB IMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997591 HOLOGIC BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HOLOGIC SURGICAL PRODUCTS COSTA RICA, SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other HER2 INFUSION THERAPY.