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

Model Number	1614N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Used one brush, one time and all bristles falling out.Blue handle ¿ proxabrush - 1614 purchased: maple garden ((b)(6)).Cust confirmed brush available for return.
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.

• Common Device Name: MANUAL TOOTHBRUSH
• 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
• MDR Report Key: 24081523
• Report Number: 1413787-2026-00251
• Device Sequence Number: 14906847
• Product Code: EFW
• UDI-Device Identifier: 00070942005647
• UDI-Public: 00070942005647
• Combination Product (Y/N): N
• 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): 01/15/2026

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: 12/10/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown