MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS TIGHT 36/BOX- PROFESSIONAL; INTERDENTAL BRUSH

Model Number	872PQ
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	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained bristles started falling off the brush right out of the package, he grabbed one out of the pack to test them after this and he said he just gently rubbed them with his fingers and bristles immediately started falling.They also said metal wire from the tip to the rubber handle barely had any bristle and the bristles seemed very fine (like more so than usual).

• Brand Name: GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS TIGHT 36/BOX- PROFESSIONAL
• 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, IL 60061 ; 8477944331
• MDR Report Key: 22006840
• Report Number: 1413787-2025-00199
• Device Sequence Number: 12098044
• Product Code: EFW
• UDI-Device Identifier: 00070942752862
• UDI-Public: 00070942752862
• 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): 05/12/2025

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: 872PQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/12/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown