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

Model Number	414PQF
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Was using proxabrush refills and the latch came undone and i swallowed it - i had to go to the hospital.I've made 7 other complaints about this in the past to you guys but nothing has been done.What a company.You all deserve to be fired, no wonder your ratings have gone down over the past years.The chief executive officer needs to be fired, manufacturing needs to be fired, quality assurance should be fired.

• Brand Name: GUM PROXABRUSH REFILLS TIGHT
• 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 ; 8133633004
• MDR Report Key: 25175835
• Report Number: 1413787-2026-00284
• Device Sequence Number: 18797669
• Product Code: EFW
• UDI-Device Identifier: 00070942752763
• UDI-Public: 00070942752763
• 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): 05/14/2026

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?: No
• Device Model Number: 414PQF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown