MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM TECHNIQUE DEEP CLEAN; TOOTHBRUSH, MANUAL

Model Number	525TPA1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
My toothbrush snapped in half during normal use has used the toothbrush like twice.States this is the second time that this has happened with this brush type.(no harm cause replacement and return envelope (b)(6) 2026).Received response (b)(6) 2026 that she has received the replacement brush but she had threw out the toothbrush after sending photo.

• Brand Name: GUM TECHNIQUE DEEP CLEAN
• 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: 25237213
• Report Number: 1413787-2026-00287
• Device Sequence Number: 9563174
• Product Code: EFW
• UDI-Device Identifier: 00070942008112
• UDI-Public: 00070942008112
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 525TPA1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown