MAUDE Adverse Event Report: SUNSTAR INC GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS; INTERDENTAL BRUSH

Model Number	872FC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained proxabrush/tight go between cleaners, at first use the brush broke off where wire met plastic base.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS
• Common Device Name: INTERDENTAL BRUSH
• Manufacturer (Section D): SUNSTAR INC; 301 e. central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS, INC; 301 e. central road; schaumburg IL 60195
• Manufacturer Contact: priya bhatia ; 301 e. central road; schaumburg, IL 60195 ; 8477944331
• MDR Report Key: 23883771
• Report Number: 1413787-2025-00247
• Device Sequence Number: 20010335
• Product Code: EFW
• UDI-Device Identifier: 00070942002448
• UDI-Public: 00070942002448
• Combination Product (Y/N): N
• 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): 12/23/2025

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: 872FC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/23/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown