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

Model Number	525
Medical Device Problem Code	Material Integrity Problem (2978)
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
Bristles are falling out of the toothbrush and into her mouth, no harm was caused.

• 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: 24434719
• Report Number: 1413787-2026-00263
• Device Sequence Number: 10244037
• 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): 02/24/2026

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: 525
• 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: 02/24/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female