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

Model Number	872
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	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A consumer had purchased and idb proxabrush and stated the wire of the brush comes out.

• Brand Name: GUM TIGHT PROXABRUSH
• Common Device Name: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICAS INC; 301 east central road; schaumburg IL 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 ; 8477944134
• MDR Report Key: 18385328
• Report Number: 1413787-2023-00085
• Device Sequence Number: 2772762
• Product Code: EFW
• UDI-Device Identifier: 00070942004848
• UDI-Public: 00070942004848
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 872
• Device Catalogue Number: RQ4
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/28/2023
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female