MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM PROXABRUSH GO-BETWEEN CLEANERS; TOOTHBRUSH, MANUAL

Model Number	3612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A consumer stated they have been using one of the gum proxabrushes and the brush has been breaking after several uses.

• Brand Name: GUM PROXABRUSH GO-BETWEEN CLEANERS
• Common Device Name: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICAS INC.; 301 east central road; schaumburg 60195
• Manufacturer (Section G): SUNSTAR AMERICAS INC.; 301 east central road; schaumburg IL 60195
• Manufacturer Contact: paula wendland ; 301 east central road; schaumburg, IL 60195
• MDR Report Key: 17971581
• Report Number: 1413787-2023-00074
• Device Sequence Number: 20612953
• Product Code: EFW
• UDI-Device Identifier: 00070942004855
• UDI-Public: 00070942004855
• 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): 10/19/2023

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: 3612
• Device Catalogue Number: RQ
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female