BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCALIZER

    MDR report key: 13005897 · Received December 14, 2021

    Report

    Report Number
    3013649990-2021-00013
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Report Date
    December 14, 2021
    Manufacturer
    HEALTH BEACONS, INC
    Product Code
    NEU
    PMA / PMN Number
    K193189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. REPORTS FOR BOTH DEVICE INVOLVED UNDER 3013649990-2021-00014.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE , DURING A LOCALIZER PROCEDURE, THE PATIENT'S INJURY WAS BRACKETED WITH TWO LOCALIZER TAGS , THAT BOTH TAGS FELL OUT OF THE EXCISED SPECIMEN PRIOR TO INTRA-OPERATIVE IMAGING SO THE PHYSICIAN HAD TO CLOSE THE PATIENT AND END THE CASE. NO OTHER INFORMATION IS AVAILABLE AT THE MOMENT. NO LOT NUMBER IS AVAILABLE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894851 LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HEALTH BEACONS, INC HB200

    Patients

    Seq Age Sex Outcome Treatment
    1 Female LOCALIZER READER