BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKER BIOZORB 4X4CM

    MDR report key: 19510794 · Received June 10, 2024

    Report

    Report Number
    MW5156093
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    June 16, 2023
    Report Date
    June 5, 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 (BRACKETED) LEFT LUMPECTOMY WITH BIOZORB PLACEMENT. ON (B)(6) 2023 PATIENT NOTED TO HAVE PAIN, ERYTHEMA AND SWELLING TO LEFT BREAST AREA ASPIRATED UNDER ULTRASOUND AND DID GROW OUT SOME SCANT STAPHYLOCOCCUS CAPRAE. SHE WAS TREATED WITH ANTIBIOTICS WITH NO REAL CHANGE. ON (B)(6) 2023 - AREA DRAINED AGAIN, CULTURE SENT OUT WITH NO GROWTH, REFERRAL TO INFECTIOUS DISEASE; (B)(6) 2024 - SURGEON HAD FOLLOW UP APPOINTMENT WITH PATIENT WHO INDICATED THEY FOLLOWED UP WITH INFECTIOUS DISEASE, WAS PRESCRIBED KEFLEX THEN BACTRIM AND ANOTHER ASPIRATION WAS COMPLETED WITH NEGATIVE CULTURES. PATIENT WITH OCCASIONAL PAIN WHEN SHE STRETCHED OUT HER ARM, SWELLING HAS GONE DOWN BUT AREA REMAIN ERYTHEMATOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189513 MARKER BIOZORB 4X4CM MARKER, RADIOGRAPHIC, IMPLANTABLE NEU FOCAL THERAPEUTICS / HOLOGIC, INC. F0404 21E19RG

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other