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

Model Number	GUM PROXABRUSH GO BETWEENS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer states she has been using 872 for years but the quality is not the same.She says she can only get 1-2 uses out of each one before the tip breaks off.No injuries were reported.Sending return envelope and replacement from department stock.

• Brand Name: PROXABRUSH GO BETWEENS CLEANERS TIGHT
• Common Device Name: MANUAL TOOTHBRUSH
• 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 ; 7737774000
• MDR Report Key: 23970020
• Report Number: 1413787-2026-00248
• Device Sequence Number: 7868772
• Product Code: EFW
• UDI-Device Identifier: 00070942002448
• UDI-Public: 00070942002448
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 01/05/2026

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: GUM PROXABRUSH GO BETWEENS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/05/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female