BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCALIZER

    MDR report key: 13994098 · Received April 4, 2022

    Report

    Report Number
    3013649990-2022-00007
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 4, 2021
    Manufacturer
    HEALTH BEACONS, INC
    Product Code
    NEU
    PMA / PMN Number
    K193189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON A LOCALIZER PROCEDURE ON FEBRUARY 21ST , BEFORE THE SURGERY 2 TAGS WERE PLACED 1.5 CM OF ONE ANOTHER, BEFORE THE INCISION THE READER ONLY SHOWED ONE TAG. DURING THE SURGERY THE PHYSICIAN WAS NOT ABLE TO FIND THE SECOND TAG AND ONLY ONE TAG WAS CONFIRMED REMOVED. AFTER THE SURGERY DURING A POST SURGICAL MAMMOGRAM THE SECOND TAG WAS FOUND STILL INSIDE THE BREAST. THE PATIENT WILL REQUIRE A SECOND SURGERY AND PLACEMENT OF A WIRE LOCATION OF THE TAG IN ORDER TO REMOVE THE SECOND TAG. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63407 LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HEALTH BEACONS, INC 09-0009

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other LOCALIZER READER| LOCALIZER TAG