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

Model Number	871FC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained wire breaking too easily and they only get one use out of it during a session before the wire breaks.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS ULTRA TIGHT
• Common Device Name: INTERDENTAL BRUSH
• Manufacturer (Section D): SUNSTAR AMERICAS, INC; 301 e. central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS, INC; 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: 21370855
• Report Number: 1413787-2025-00174
• Device Sequence Number: 15583163
• Product Code: EFW
• UDI-Device Identifier: 00070942002684
• UDI-Public: 00070942002684
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 871FC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/12/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown