BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEWAVE SYSTEM

    MDR report key: 7239913 · Received February 3, 2018

    Report

    Report Number
    3010817521-2018-00001
    Event Type
    Injury
    Date Received
    February 3, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 13, 2018
    Manufacturer
    SONENDO, INC.
    Product Code
    ELC
    UDI-DI
    00858395006226
    PMA / PMN Number
    160905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WHEN USED WITH THE CONSOLE IS REFERRED TO AS THE GENTLEWAVE SYSTEM. NEITHER SINGLE USE DEVICE/HANDPIECE NOR THE CONSOLE WAS RETURNED FOR EVALUATION. SINCE THE HANDPIECE WAS NOT RETURNED, THE MODEL AND LOT NUMBER COULD NOT BE DETERMINED. THIS IS SONENDO'S FIRST ELECTRONIC REPORT AND IS LATE DUE TO THE ENROLLMENT PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT TREATED EARLIER IN THE DAY HAD GONE TO THE HOSPITAL DUE TO SWELLING IN THE NECK, NO BRUISING OR BLEEDING WAS REPORTED. CUSTOMER SUBSEQUENTLY REPORTED THAT PATIENT WAS ADMINISTERED A BREATHING TUBE WHICH HAS SINCE BEEN REMOVED. THE CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED FORM THE HOSPITAL AND RETURNED HOME. ENDODONTIST (CUSTOMER/USER) INITIALLY STATED THAT SWELLING COULD HAVE BEEN DUE TO AN ALLERGIC REACTION TO ANESTHESIA. THE CUSTOMER SUBSEQUENTLY STATED THAT IT COULD BE A SODIUM HYPOCHLORITE INCIDENT. THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE PATIENT INDICATED FEELING PAIN AND THUS THE CUSTOMER RE-ANESTHETIZED THE PATIENT. AFTER ADMINISTERING MORE ANESTHESIA, THE CUSTOMER REPORTED THAT HE COMPLETED THE PROCEDURE AND NOTED THAT THE RESULTS LOOKED GOOD. THE CUSTOMER REPORTED THAT THE PATIENT WAS FINE AFTER THE PROCEDURE AND LEFT THE OFFICE WITHOUT ISSUE. SINCE THE TIME OF THE INITIAL EVENT, THE CUSTOMER HAS NOTED THAT THE PATIENT'S CONDITION IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83308 GENTLEWAVE SYSTEM ULTRASONIC SCALER ELC SONENDO, INC. UNKNOWN UNKNOWN 00858395006226

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R