FDA Adverse Event Injury Summary report: N

GENTLEWAVE

MDR report key: 21978498 · Received May 7, 2025

Report

Report Number
MW5170061
Event Type
Injury
Date Received
May 7, 2025
Date of Event
June 1, 2021
Report Date
May 1, 2025
Manufacturer
SONENDO INC.
Product Code
ELC
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY ENDODONTIST, DR. (B)(6) OF (B)(6), USED THE GENTLEWAVE SYSTEM BY SONENDO, INC. (HTTPS://GENTLEWAVE.COM/) TO CLEAN AND PREPARE A ROOT CANAL FOR TOOTH 15. THE HIGHLY PRESSURIZED HYDRAULICALLY CONTROLLED SODIUM HYPOCHLORITE (BLEACH) FROM THIS MACHINE SPRAYED BLEACH INTO MY LEFT MAXILLARY SINUS CAUSING A SEVERE BURN IN MY LEFT MAXILLARY SINUS WHEREBY I HAD BLOOD AND BLEACH COMING OUT OF MY LEFT NOSTRIL. I SUSTAINED A SEVERE CHEMICAL BURN IN MY LEFT MAXILLARY SINUS WITH SEVERE DAMAGE TO BOTH TISSUES AND NERVES IN MY MAXILLARY SINUS AND NEARBY TISSUES LEADING TO CHRONIC SINUSITIS AND NEURALGIA, INCLUDING TRIGEMINAL NEURALGIA, IN THE LEFT PART OF MY FACE UNDER MY LEFT EYE. THE PAIN FROM THE INCIDENT RADIATES AROUND MY LEFT EYE AND SOMETIMES CAUSES BLURRY VISION WITH SOME PAIN RADIATING TO THE UPPER LEFT PART OF MY HEAD. MY ABILITY TO PRODUCE MUCUS IN MY LEFT MAXILLARY SINUS HAS BEEN COMPROMISED DUE TO THE CHEMICAL DAMAGE TO THE MUCUS MEMBRANE IN THAT AREA AND AS SUCH MY LEFT MAXILLARY SINUS FEELS VERY DRY AND UNCOMFORTABLE. IN COLD WEATHER, AS I BREATH IN COLD AIR, IT STARTS TO HURT AND BOTHER ME. IN THE EVENINGS, I WAKE UP AND AM UNABLE TO GO BACK TO SLEEP DUE TO THE PAIN AND DISCOMFORT. THE ISSUES CAUSED BY THIS INCIDENT ARE PERMANENT AND CHRONIC UNFORTUNATELY. TO THIS DAY I AM IN PAIN FROM THE INCIDENT THAT OCCURRED WITH THIS MEDICAL DEVICE. I HAD MANY DIFFERENT TESTS DONE. MANY CT SCANS AND MANY X-RAYS. ALL OF THEM SHOWED THE SAME ISSUE OF MY LEFT MAXILLARY SINUS HAVING BEEN CHEMICALLY BURNED VERY BADLY AFTER THIS INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
346475 GENTLEWAVE SCALER, ULTRASONIC ELC SONENDO INC.

Patients

Seq Age Sex Outcome Treatment
1 Male Disability| L GABAPENTIN.| NASAL STEROID SPRAY.| TEGRETOL.