MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC. PHILIPS SONICARE TOOTHBRUSH HEAD; TOOTHBRUSH, POWERED

Model Number PHILIPS SONICARE

Device Problems Product Quality Problem (1506); Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Date 02/05/2023

Event Type  Injury  

Event Description

Philips sonicare toothbrush heads have a quality control and manufacturing problem.The location of the injection mold for the plastic molding is leaving hard extruded plastic at the injection site.This plastic then cut the lips of myself and other consumers.Philips should quickly recall all the affected toothbrush heads manufactured in this facility so other consumers do not receive mouth and lip cuts.Philips has not properly responded to my direct complaint about this product.This is a serious matter and needs attention before someone is really hurt.

• Brand Name: PHILIPS SONICARE TOOTHBRUSH HEAD
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC.
• MDR Report Key: 16337400
• MDR Text Key: 309295970
• Report Number: MW5114809
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PHILIPS SONICARE
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White