BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONENDO GENTLEWAVE SYSTEM

    MDR report key: 11599848 · Received March 31, 2021

    Report

    Report Number
    3010817521-2021-00001
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 26, 2021
    Manufacturer
    SONENDO, INC.
    Product Code
    ELC
    UDI-DI
    00858395006226
    PMA / PMN Number
    K160905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DOCTOR RETURNED PROCEDURE INSTRUMENT (PI) USED WITH THE PATIENT AND THE PI WAS TESTED BY SONENDO. NO DEFECT OF PRODUCT ALLEGED. DEVICE HISTORY RECORD OF THE PI WAS REVIEWED; NO NONCONFORMITIES IN THE DHR. WITH RESPECT TO THE PATIENT'S COMMENTS REGARDING THE REPORTED INCIDENT, THE MANUFACTURER HAS NOT RECEIVED ANY COMMUNICATION FROM A MEDICAL PROFESSIONAL TO CONFIRM OR DENY THE PATIENT'S REPORT TO THE DOCTOR. THE DOCTOR INDICATES PATIENT IS NO LONGER COMMUNICATING WITH HIM, DESPITE SEVERAL ATTEMPTS TO CONTACT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT WHILE WORKING ON TOOTH#2 IN A NECROTIC TREATMENT, THERE WAS FOAMING AT THE PLATFORM. THE DOCTOR READJUSTED A COUPLE TIMES BUT THE FOAMING CONTINUED, PATIENT REPORTED TASTING BLEACH. HE INTERRUPTED THE TREATMENT. THE DOCTOR DESCRIBED THAT THE PATIENT HAD BURNING IN THE THROAT. HE FOLLOWED UP WITH THE PATIENT FOR 10 DAYS AND THE PATIENT REPORTED SHE WAS VERY HOARSE AND LOST HER VOICE AND MISSED WORK. THE PATIENT SELF-REFERRED TO ER, ENT AND VOICE THERAPY. THE DOCTOR CONTINUED TO FOLLOW UP WITH THE PATIENT, BUT AFTER 10 DAYS THE PATIENT STOPPED RESPONDING TO HIS MESSAGES AND MISSED FOLLOW UP TO FINISH THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491400 SONENDO GENTLEWAVE SYSTEM ULTRASONIC SCALER ELC SONENDO, INC. FG-002-00001 00858395006226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other