BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCALIZER

    MDR report key: 10228606 · Received July 3, 2020

    Report

    Report Number
    3013649990-2020-00002
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    May 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    HEALTH BEACONS, INC.
    Product Code
    NEU
    PMA / PMN Number
    K190932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON 01-JUN-2020 HEALTH BEACONS RECEIVED COMPLAINT (B)(4). THE COMPLAINT INDICATED THAT THE LOCALIZER CAPSULE (SHEATH) WAS MISSING FROM THE TAG WHEN IT WAS REMOVED FROM PATIENT. THE TAG WAS EXPOSED DURING SURGERY AND PLACED ON BACK TABLE. THE REPRESENTATIVE INDICATED THAT THE SURGEON THOUGHT SHE MAY HAVE TOUCHED THE TAG WITH THE ELECTROCAUTERY DEVICE. SEVERAL REQUESTS FOR ADDITIONAL INFORMATION TO FACILITATE THE INVESTIGATION OF THE COMPLAINT HAVE BEEN SUBMITTED AS FOLLOWS: WEEK OF 01-JUN-2020 - TEXT WAS SENT TO REPRESENTATIVE, INDICATING THAT WE NEEDED ADDITIONAL INFORMATION TO INVESTIGATE ISSUE. - NO RESPONSE. 09-JUN-2020 - EMAILED INDICATING THAT THE COMPLAINT WOULD BE HANDLED AS A REPORTABLE EVENT, AND ASKING IF THE SHEATH WAS DISCOVERED DURING PATHOLOGY OF THE RESECTED TISSUE, OR IF AN ULTRASOUND WAS CONDUCTED ON THE PATIENT TO LOOK FOR ANY TRACE OF THE SHEATH IN THE BREAST. RESPONSE: REPRESENTATIVE INDICATED THAT THEY DID NOT HAVE THE INFORMATION BUT WOULD ASK THE PHYSICIAN ON 12-JUN-2020. 12-JUN-2020 - FOLLOW UP EMAIL WAS SENT ASKING IF THE PHYSICIAN HAD BEEN ABLE TO PROVIDE ADDITIONAL INFORMATION. - NO RESPONSE. 17-JUN-2020 - FOLLOW UP EMAIL WAS SENT REQUESTING INFORMATION. RESPONSE: ON 19-JUN-2020 REPRESENTATIVE SENT A TEXT TO THE PHYSICIAN REQUESTING INFORMATION. 30-JUN-2020: REPRESENTATIVE VISITED THE HOSPITAL TO FOLLOW UP IN PERSON AS THE SURGEON HAS NOT RESPONDED TO VOICEMAILS AND TEXTS. AS IT HAS BEEN DIFFICULT TO OBTAIN INFORMATION FROM THE HOSPITAL BECAUSE OF PERSONNEL RESTRICTIONS DUE TO COVID-19, WE HAVE NOT BEEN ABLE TO FULLY UNDERSTAND THE EVENT, BUT OUT OF AN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS INCIDENT AS A DEVICE MALFUNCTION. THE SHEATH MAY HAVE MELTED FULLY OR PARTIALLY FROM THE TAG, LEAVING IT UNRECOGNIZABLE BUT STILL IN THE TISSUE; IT MAY HAVE SEPARATED BUT REMAINED IN THE EXCISED TISSUE OR IT MAY HAVE SEPARATED AND REMAINED IN THE BREAST (THIS IS THE LEAST LIKELY SCENARIO, BECAUSE IT WOULD MEAN IT ALSO MIGRATED). EVEN IN THE EVENT THE SHEATH REMAINS IN THE PATIENT'S BREAST, IT IS NOT BEING CONSIDERED A SERIOUS INJURY, AS THE DEVICE IS APPROVED AS A PERMANENT IMPLANT. IF ADDITIONAL INFORMATION ABOUT THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694435 LOCALIZER TAG APPLICATOR S NEU HEALTH BEACONS, INC. HB300-05 43084

    Patients

    Seq Age Sex Outcome Treatment
    1