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

Model Number	3614PQ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained about wire keeps snapping during use of proxabrush and needed constant replacing.

• 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 60195 ; 5514048470
• MDR Report Key: 21071769
• Report Number: 1413787-2025-00165
• Device Sequence Number: 20926015
• Product Code: EFW
• UDI-Device Identifier: 00070942004909
• UDI-Public: 00070942004909
• 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): 01/03/2025

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: 3614PQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown