BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOZORB

    MDR report key: 19584866 · Received June 20, 2024

    Report

    Report Number
    MW5156441
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 3, 2022
    Report Date
    June 15, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED BIOZORB BREAST TUMOR BED MARKER. CONTINUED PAIN BRUISING HARD LUMP IN BREAST LEFT SIDE. WAS TOLD DURING CONSULTATION WHEN CONSENT WAS OBTAINED THIS DEVICE WOULD ABSORB INTO MY BODY WITHIN 12 MONTHS. TWO YEARS LATER STILL PAINFUL HARD LUMP IN BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762613 BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female