MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM® PROXABRUSH® GO-BETWEENS® (1.6MM)WIDE 8CT;; INTERDENTAL BRUSH

Model Number	1614N
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	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer used interdental brushes and encountered the issue that the brush breaks and get stuck between their teeth.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS® (1.6MM)WIDE 8CT
• Common Device Name: INTERDENTAL BRUSH
• 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; schaumburg 60195 ; 8477944331
• MDR Report Key: 20262035
• Report Number: 1413787-2024-00143
• Device Sequence Number: 21045450
• Product Code: EFW
• UDI-Device Identifier: 00070942000840
• UDI-Public: 00070942000840
• 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): 09/19/2024

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: 1614N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown