BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONENDO GENTLEWAVE SYSTEM

    MDR report key: 9863292 · Received March 21, 2020

    Report

    Report Number
    3010817521-2019-00001
    Event Type
    Injury
    Date Received
    March 21, 2020
    Date of Event
    June 5, 2019
    Report Date
    August 26, 2019
    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 DOCTOR REPORTED THAT THE PATIENT HAD A HYPOCHLORITE EXTRUSION INTO THE FACIAL TISSUES. THE PATIENT HAD IMMEDIATE PAIN AND SWELLING FOLLOWED BY BRUISING. PATIENT SOUGHT FOLLOW UP EMERGENCY TREATMENT FOR PAIN. PATIENT SEEMED OKAY AT 6 WEEK FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326754 SONENDO GENTLEWAVE SYSTEM ULTRASONIC SCALER ELC SONENDO, INC. FG-001-00025 UNKNOWN 00858395006301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other