MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM PROXABRUSH GO BETWEENS; TOOTHBRUSH, MANUAL

Model Number	872RQ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Proxabrushes started breaking during use and not lasting as long as they usually do before breaking happened with the two packs she purchased at walmart.(no harm was caused and we have sent a replacement and return envelope).

• Brand Name: GUM PROXABRUSH GO BETWEENS
• 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: 24150314
• Report Number: 1413787-2026-00252
• Device Sequence Number: 9501991
• Product Code: EFW
• UDI-Device Identifier: 00070942002448
• UDI-Public: 00070942002448
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 872RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/22/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown