MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. PROXABRUSH; 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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained that tight go between cleaner is breaking off at the base.3-4 have broken from a 10 pack.There was no injury reported.

• Brand Name: PROXABRUSH
• 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 60195 ; 8477944331
• MDR Report Key: 22821419
• Report Number: 1413787-2025-00221
• Device Sequence Number: 9760425
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown