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

Model Number	872RQ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated the tip broke off the handle after 4 uses and was lodged in her teeth.She was able to remove it on her own.She said this is not the first time this has happened.She's been using them for years without issue but lately they are breaking with little use.No injury was reported nor did she seek medical attention.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS 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: paula wendland ; 301 e. central road; schaumburg, IL 60061 ; 8477944331
• MDR Report Key: 22821411
• Report Number: 1413787-2025-00222
• Device Sequence Number: 18582041
• Product Code: EFW
• UDI-Device Identifier: 00070942002448
• UDI-Public: 00070942002448
• 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): 08/15/2025

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: 872RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown