MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE PROTECTIVECLEAN 5100; TOOTHBRUSH, POWERED

Model Number HX6850

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/08/2023

Event Type  Injury  

Event Description

While brushing my teeth the internal mechanism holding the vibrating metal post failed.The toothbrush head vibrated violently and pinched the corner of my mouth.It was also extremely loud.This is the 2nd time this mechanism has failed with this sonicare product.It is very common and many reviews, including a large amount of more recent ones, have the exact same faulty internal mechanism fail.Philips seems to not care, at all.Fcc id: (b)(4).

• Brand Name: PHILIPS SONICARE PROTECTIVECLEAN 5100
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC
• MDR Report Key: 16940533
• MDR Text Key: 315415340
• Report Number: MW5117554
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX6850
• Device Catalogue Number: 049-11-5919
• Device Lot Number: 20109-HX68
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2023
• Patient Sequence Number: 1