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

Model Number	3614RQ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer used one in the pack and the bristles came out immediately once put in between their tooth.They were able to get all the bristles out of their mouth, however the wire was missing all the bristles when using.
Additional Manufacturer Narrative
Complaint not confirmed.

• Brand Name: GUM® PROXABRUSH GO-BETWEENS® CLEANERS
• Common Device Name: INTERDENTAL BRUSH
• Manufacturer (Section D): SUNSTAR INC; sunstar americas, inc; 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: 23493687
• Report Number: 1413787-2025-00241
• Device Sequence Number: 18420931
• Product Code: EFW
• UDI-Device Identifier: 00070942002479
• UDI-Public: 00070942002479
• 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): 11/06/2025

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: 3614RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/06/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown