BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONENDO GENTLEWAVE SYSTEM

    MDR report key: 9863287 · Received March 21, 2020

    Report

    Report Number
    3010817521-2020-00002
    Event Type
    Injury
    Date Received
    March 21, 2020
    Date of Event
    October 10, 2019
    Report Date
    January 6, 2020
    Manufacturer
    SONENDO, INC.
    Product Code
    ELC
    UDI-DI
    00858395006301
    PMA / PMN Number
    K160905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS ON PATIENT'S UPPER MOLAR. ABOUT 90 SECONDS INTO THE NAOCI CYCLE, THE PATIENT RAISED HER HANDS AND SAID SHE WAS FEELING PAIN. THE DOCTOR DISCONTINUED THE GENTLEWAVE PROCEDURE, RINSED WITH DISTILLED WATER. SWELLING AND BRUISING WAS NOTED VERY QUICKLY. THE DOCTOR SENT THE PATIENT TO THE ENT IN THE BUILDING. THE PATIENT WAS GIVEN AN RX FOR STEROIDS AND PAIN MEDS. THE PATIENT HAD SWELLING AND BRUISING FOR A FEW WEEKS BUT IT EVENTUALLY RESOLVED AND SHE IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326750 SONENDO GENTLEWAVE SYSTEM ULTRASONIC SCALER ELC SONENDO, INC. FG-001-00025 UNKNOWN 00858395006301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other