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	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026: the wire brush from a green handled brush dislodged from the holder and stuck in my teeth.It may still be inside my throat or esophagus.I am pursuing medical advice what to do.On (b)(6) 2026: you're saying it is safe to swallow a 3/4¿ long piece of twisted stainless-steel wire!? i hope! because i¿m afraid it will become lodged inside if i¿ve swallowed it.If so, i can only hope it passes without harm.I messaged my doctor for her advice.This was not the tight size.It¿s the medium green ones and this was not the first time one had come out the rubber handle.The prior times, i was able to remove the brush part from my gums and mouth with my fingers.I tried your tight size brushes and found the cut and twist of the end wires flared and were difficult to get between my teeth, not much narrower than the green medium ones.I started to report this, but i let it go and purchased others.The brush is pulling out because there is nothing to prevent it, like a bent base of the wire in the holder.I would not want replacement product.I believe it would happen again.On (b)(6) 2026: after closer look, the wire broke at the handle, which would have been a minimal length of bare wire.Hopefully there will be no complications.; there haven't been as yet.The wires bend easily when used between back teeth and likely fatigued from multiple uses.

• 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: 24918386
• Report Number: 1413787-2026-00280
• Device Sequence Number: 18756893
• 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): 04/17/2026

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: 872RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown