MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM® PROXABRUSH GO-BETWEENS® CLEANERS WIDE 10CT; INTERDENTAL BRUSH

Model Number	3614RQ
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated that the tip of the proxabrush came off and she swallowed it.Customer was asked if it got stuck between the teeth and came off and she said she did not know but she is sure she swallowed it.No injury reported.

• Brand Name: GUM® PROXABRUSH GO-BETWEENS® CLEANERS WIDE 10CT
• 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 ; 8477944331
• MDR Report Key: 23760084
• Report Number: 1413787-2025-00246
• Device Sequence Number: 15995062
• 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): 12/09/2025

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: 11/11/2025
• Initial Report FDA Received Date: 12/09/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown