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

Model Number	872RQ4
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	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained bristles of the proxabrush fell off of the brush as soon as they started using it, they rinsed out their mouth out immediately after and made sure they didn't swallow any.There was no harm caused however they were scared.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®
• 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: 22649751
• Report Number: 1413787-2025-00219
• Device Sequence Number: 18295104
• Product Code: EFW
• UDI-Device Identifier: 00070942004848
• UDI-Public: 00070942004848
• 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): 07/29/2025

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: 872RQ4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown