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

Model Number	3612RQ
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	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint not confirmed.
Event or Problem Description
Consumer complained that the go between cleaners are made very flimsy now.She's used tight and moderate for years and has always been able to use them for over a week and now they don't last more than 1 day.The bristles fell out and the wire broke.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS® CLEANERS
• Common Device Name: INTERDENTAL BRUSH
• 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: priya bhatia ; 301 e. central road; schaumburg, IL 60061 ; 8477944331
• MDR Report Key: 22590612
• Report Number: 1413787-2025-00211
• Device Sequence Number: 15725243
• Product Code: EFW
• UDI-Device Identifier: 00070942002462
• UDI-Public: 00070942002462
• Combination Product (Y/N): N
• 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): 07/24/2025

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: 3612RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown