BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC LOCALIZER

    MDR report key: 16947667 · Received May 16, 2023

    Report

    Report Number
    MW5117596
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    November 9, 2022
    Report Date
    May 12, 2023
    Manufacturer
    HOLOGIC, INC./HEALTH BEACONS, 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

    PATIENT BIOPSY PERFORMED ON (B)(6) 2022. LOCALIZER MARKER PLACED (B)(6) 2022, IN BREAST DIAG. DEPARTMENT. DURING SURGERY (B)(6) 2022, TO REMOVE CA (CANCER) LESION WITH MARKER, MARKER WAS REMOVED BUT PATH (PATHOLOGY) REPORTED STATED NO CA (CANCER) IDENTIFIED IN TISSUE, PATIENT RETURNED TO BREAST IMAGING (B)(6) TO HAVE LESION REMARKED A SECOND TIME AND SECOND SURGERY (B)(6) 2022, COMPLETED TO REMOVE MARKER WITH CA (CANCER) LESION ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907670 HOLOGIC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HOLOGIC, INC./HEALTH BEACONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other