MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS; 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	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint not confirmed.
Event or Problem Description
Customer purchased gum proxabrush tight and had a brush head break only 4 days into use so they had to use a new one which broke 3 days into use.Upon getting further information customer mentioned toothbrush broke after only 4 days of use." " after only a couple of days of use, the wire broke that held the brush head and the brush head got stuck between their teeth.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS
• Common Device Name: INTERDENTAL BRUSH
• 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: 22378515
• Report Number: 1413787-2025-00207
• Device Sequence Number: 21191362
• 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): 07/01/2025

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: 06/04/2025
• Initial Report FDA Received Date: 07/01/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown