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

Model Number	871RQ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer used idb and it broke off in between her teeth.Although there was no damage to permanent structure, customer did visit to urgent care to remove broken piece of idb.Her jaw is sore from having her jaw open for a long amount of time.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS ULTRA TIGHT
• 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: 23390853
• Report Number: 1413787-2025-00240
• Device Sequence Number: 15962159
• Product Code: EFW
• UDI-Device Identifier: 00070942002431
• UDI-Public: 00070942002431
• 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): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 871RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/27/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown