MAUDE Adverse Event Report: Sunstar Americas, Inc. GUM Proxabrush Go Betweens Cleaners Tight; Toothbrush, Manual

Model Number	872PQ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer was wedging the brush in between her teeth in the bottom quadrant in the front and it broke off the brush was stuck in between her teeth.It was stuck between 22 and 23.Consumer pushed the broken brush out with her fingers.

• Brand Name: GUM Proxabrush Go Betweens Cleaners Tight
• 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 ; +1(813)363-3004
• MDR Report Key: 50856473
• Report Number: 1413787-2026-00310
• Device Sequence Number: 18554712
• Product Code: EFW
• UDI-Device Identifier: 00070942752862
• UDI-Public: 00070942752862
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 872PQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown