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

Model Number	3614RQ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction

• Brand Name: GUM Proxabrush Go Betweens Cleaners Wide
• 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: 50441331
• Report Number: 1413787-2026-00306
• Device Sequence Number: 21053095
• Product Code: EFW
• UDI-Device Identifier: 00070942002479
• UDI-Public: 00070942002479
• 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): 08/25/2026

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: 3614RQ
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/25/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown