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

Model Number	871RQ
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental damage caused by product hello, i am contacting you regarding my purchase of gum proxabrush go-betweens ¿ ultra tight (order id: (b)(4).Despite being advertised as soft and safe for gum health, these interdental brushes were extremely hard and rigid when used.During normal use, the excessive hardness caused damage to my tooth, resulting in a chipped tooth tip.This is completely unacceptable for a dental care product.Additionally, the brushes showed poor construction and instability, making them unsafe for oral use.A product intended for ultra-tight spaces should be gentle and controlled, not strong enough to cause physical dental damage.This product is clearly not as described and represents a serious safety issue.

• Brand Name: GUM ULTRA-TIGHT PROXABRUSH
• Common Device Name: TOOTHBRUSH, MANUAL
• 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: darren scheer ; 301 e. central road; schaumburg, IL 60195 ; 8133633004
• MDR Report Key: 24252418
• Report Number: 1413787-2026-00254
• Device Sequence Number: 13176109
• Product Code: EFW
• UDI-Device Identifier: 00070942002431
• UDI-Public: 00070942002431
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 871RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown