MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS ULTRA TIGHT; MANUAL TOOTHBRUSH

Model Number	871RQ
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	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Was using 871rq and the tip broke and stuck between teeth.

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS ULTRA TIGHT
• 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; schaumburg, IL 60195 ; 8477944331
• MDR Report Key: 20302678
• Report Number: 1413787-2024-00144
• Device Sequence Number: 18073947
• Product Code: EFW
• UDI-Device Identifier: 00070942002431
• UDI-Public: 00070942002431
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/25/2024

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: 871RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown