BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONENDO GENTLEWAVE SYSTEM

    MDR report key: 9863280 · Received March 21, 2020

    Report

    Report Number
    3010817521-2020-00003
    Event Type
    Injury
    Date Received
    March 21, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 20, 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

    AFTER 4 MINUTES INTO THE NAOCI CYCLE, THE PATIENT JUMPED OUT OF THE CHAIR AND SAID HE COULD NOT BREATH. THERE WAS BLEEDING FROM THE TOOTH, BUT NOT EXCESSIVE. THE DOCTOR THOUGHT PATIENT INGESTED SOME NAOCI SO HE GAVE THE PATIENT WATER TO RINSE; AND AFTER FEW MINUTES THE PATIENT WAS ABLE TO CONTINUE WITH THE TREATMENT. THE TREATMENT WAS COMPLETED. THE PATIENT DID NOT HAVE SWELLING OR BRUISING AT THE TIME. HOWEVER, THE PATIENT WAS IN ER THAT NIGHT WHEN THE DOCTOR CALLED TO FOLLOW-UP. THE PATIENT STATED HE HAD EXCESSIVE AMOUNT OF NOSE BLEED AND HAD DIFFICULTY IN BREATHING. THE PATIENT WAS SENT HOME WITH AUGMENTIN 875MG EVERY 12 HOURS FOR 7 DAYS. AFTER 8 DAYS FOLLOWING THE INCIDENT, THE PATIENT CLAIMED HE WAS STILL CONGESTED, BUT NOSE BLEEDING HAD STOPPED. THE PATIENT HAS A FOLLOW-UP APPOINTMENT WITH HIS PHYSICIAN (GENERAL PRACTITIONER). THE DOCTOR ASKED THE PATIENT TO SCHEDULE AN APPOINTMENT FOLLOWING THE APPOINTMENT WITH HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327083 SONENDO GENTLEWAVE SYSTEM ULTRASONIC SCALER ELC SONENDO, INC. FG-001-00025 UNKNOWN 00858395006301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other