MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM TECHNIQUE DEEP CLEAN; TOOTHBRUSH, MANUAL

Model Number	525D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The toothbrush caused my teeth to break.

• Brand Name: GUM TECHNIQUE DEEP CLEAN
• Common Device Name: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.; 301 e. central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS, INC; 301 e. central road; schaumburg IL 60195
• Manufacturer Contact: darren scheer ; 301 e. central road; schaumburg, IL 60195 ; 8133633004
• MDR Report Key: 25177017
• Report Number: 1413787-2026-00285
• Device Sequence Number: 10624475
• Product Code: EFW
• UDI-Device Identifier: 00070942008112
• UDI-Public: 00070942008112
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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?: No
• Device Model Number: 525D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown