MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC GUM® TECHNIQUE® DEEP CLEAN COMPACT/SOFT TOOTHBRUSH; PROFESSIONAL; MANUAL TOOTHBRUSH

Model Number	525PH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an email this morning from stephanie kiefer¿s office regarding patient feedback on the 525 tech deep clean compact soft toothbrush.They mentioned that the bristles have been falling out while patients are brushing their teeth.

• Brand Name: GUM® TECHNIQUE® DEEP CLEAN COMPACT/SOFT TOOTHBRUSH; PROFESSIONAL
• 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: priya bhatia ; 301 e. central road; vernon hills, IL 60061 ; 8477944331
• MDR Report Key: 22581871
• Report Number: 1413787-2025-00210
• Device Sequence Number: 7091611
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: 525PH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown