BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONENDO GENTLEWAVE SYSTEM

    MDR report key: 9984692 · Received April 22, 2020

    Report

    Report Number
    3010817521-2019-00002
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    August 21, 2019
    Report Date
    April 20, 2020
    Manufacturer
    SONENDO, INC.
    Product Code
    ELC
    UDI-DI
    00858395006226
    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 NOSE BLEEDING AFTER COMPLETING THE GENTLEWAVE PROCEDURE. THE NEXT DAY THE PATIENT REPORTED NASAL DRAINAGE; AND IT CONTINUED FOR TWO DAYS. AFTER TWO WEEKS, THE PATIENT WAS SENT TO AN ENT DOCTOR AND WAS DIAGNOSED WITH ORO-ANTRA FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450536 SONENDO GENTLEWAVE SYSTEM ULTRASONIC SCALER ELC SONENDO, INC. FG-002-00001 00858395006226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other