BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC LOCALIZER

    MDR report key: 16947556 · Received May 16, 2023

    Report

    Report Number
    MW5117590
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    March 20, 2022
    Report Date
    May 12, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOLOGIC LOCALIZER BREAST TISSUE MARKER MIGRATED AWAY FROM LESION SITE PRIOR TO SURGERY, WHEN SURGERY PERFORMED UNABLE TO FIND MARKER, SIGNIFICANT HEMATOMA AT LOCALIZER SITE, REQUIRED ADDITIONAL PROCEDURE TO REMARK CA LESION AND REPEAT SURGERY TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907664 HOLOGIC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other THERAPY END DATE.| THERAPY START DATE.