BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOMARK LP

    MDR report key: 11646261 · Received April 9, 2021

    Report

    Report Number
    3014680735-2021-00003
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 9, 2021
    Manufacturer
    SONAVEX, INC.
    Product Code
    NEU
    PMA / PMN Number
    K180621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRECAUTIONARY REMOVAL INITIATED BY SURGEON. NO REPORTS OF PATIENT PAIN OR DISCOMFORT.

    Description of Event or Problem · 1

    ECHOMARK WAS REMOVED UNDER LOCAL ANESTHESIA ABOUT 4 MONTHS AFTER INITIAL IMPLANTATION DUE TO MIGRATION AND THE PATIENT WANTED IT REMOVED. NO COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542831 ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER NEU SONAVEX, INC. 2000 P15069

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other