FDA Adverse Event Injury Summary report: N

PHYLIAN SONIC ELECTRIC TOOTHBRUSH

MDR report key: 16254057 · Received January 26, 2023

Report

Report Number
MW5114534
Event Type
Injury
Date Received
January 26, 2023
Date of Event
January 20, 2023
Report Date
January 25, 2023
Manufacturer
WENZHOU LIANGTE ELECTRIC CO., LTD.
Product Code
JEQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THE PRODUCT IS PHYLIAN SONIC ELECTRIC TOOTHBRUSH( SKU HH0006015-BLK, MODEL HH06015, 3.7V BATTERY, MANUFACTURER WENZHOU LIANGTE ELECTRIC CO., LTD., (B)(4). I STARTED USING THE PRODUCT ON (B)(6) 2022 - DAOR INTO ILY ON CLEANING MODE AND 1-2 TIMES A WEEK FOR STAINS AND WHITENING AFTER CLEANING. THE PRODUCT BOX CONTAINED 8 BRUSH HEADS. ON THREE OCCASIONS THE BRISTLES CAME OFF THE BRUSH HEAD. I ALMOST SWALLOWED THE BRISTLES ON (B)(6) 2023. THE BRUSH HEADS HAVE 16 CLUSTERS OF BRISTLES. EACH TIME THE 2 CLUSTERS CAME LOOSE IN MY MOUTH FROM DIFFERENT POSITIONS OF THE BRUSH HEAD. THE OTHER BRUSH HEADS FELL OFF AFTER ABOUT 8-10 USES. I DID NOT PRESS THE BRUSH HEAD HARD AGAINST MY TEETH, AND I MOVED THE BRUSH SLOWLY ACROSS MY TEETH. I RINSE THE BRUSH IN FRESH WATER, TURNED THE BRUSH ON TO SHAKE OFF EXCESS WATER, AND STORED IT IN THE PROVIDED CASE. THE TOOTHBRUSH NEVER FELL OVER ON THE SINK OR INTO THE SINK, AND NEVER FELL ON THE FLOOR. NO OTHER PERSON IN THE FAMILY USED ON PHYLIAN ELECTRIC TOOTHBRUSH. I READ THE USER MANUAL BEFORE USE, AND SAW THE RECOMMENDED DIRECTION TO REPLACE THE BRUSH HEAD ABOUT EVERY 3 MONTHS. THE THREE BRUSH HEADS, AS I STATED LASTED, A FEW DAYS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
377772 PHYLIAN SONIC ELECTRIC TOOTHBRUSH TOOTHBRUSH, POWERED JEQ WENZHOU LIANGTE ELECTRIC CO., LTD. HH06015
377773 PHYLIAN SONIC ELECTRIC TOOTHBRUSH TOOTHBRUSH, POWERED JEQ WENZHOU LIANGTE ELECTRIC CO., LTD. HH06015
377774 PHYLIAN SONIC ELECTRIC TOOTHBRUSH TOOTHBRUSH, POWERED JEQ WENZHOU LIANGTE ELECTRIC CO., LTD. HH06015

Patients

Seq Age Sex Outcome Treatment
1 76 YR Male COUMADIN, ATORVASTATIN.