MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. PROXABRUSH; TOOTHBRUSH, MANUAL

Model Number	1614N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I have used your proxabrushes for a few years now but have a problem with the container i am using as two of the brushes fell off the stems when i was first using them.Never happened before.The wire broke and the head came off.
Additional Manufacturer Narrative
Our reporting system experienced technical difficulty and thus this report is delayed.Our vendor, iqvia, has notified us that we have ran into a bug that requires a patch that will be released soon.

• Brand Name: PROXABRUSH
• Common Device Name: TOOTHBRUSH, MANUAL
• 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: darren scheer ; 301 e. central road; schaumburg, IL 60195 ; 8133633004
• MDR Report Key: 24067069
• Report Number: 1413787-2026-00250
• Device Sequence Number: 21399192
• Product Code: EFW
• UDI-Device Identifier: 00070942000840
• UDI-Public: 00070942000840
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: 1614N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown