MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM® ORTHODONTIC KIT; MANUAL TOOTHBRUSH

Model Number	124RQB
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	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained about the bristles on the orthodontic toothbrush were falling out while brushing.

• Brand Name: GUM® ORTHODONTIC KIT
• 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 60061
• Manufacturer Contact: priya bhatia ; 301 e. central road; schaumburg, IL 60195 ; 8477944331
• MDR Report Key: 22376823
• Report Number: 1413787-2025-00205
• Device Sequence Number: 7972233
• Product Code: EFW
• UDI-Device Identifier: 00070942306799
• UDI-Public: 00070942306799
• 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): 07/01/2025

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: 124RQB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 07/01/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown