MAUDE Adverse Event Report: SUNSTAR INC GUM PROXABRUSH; INTERDENTAL BRUSH

Model Number 1414AR

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Customer used 2 proxabrushes resulting in wire head of brush breaking from the unit after use.

• Brand Name: GUM PROXABRUSH
• Type of Device: INTERDENTAL BRUSH
• Manufacturer (Section D): SUNSTAR INC; 301 e. central rd; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR INC
• Manufacturer Contact: paula wendland ; schaumburg, IL 60195 ; 7733554024
• MDR Report Key: 19106765
• MDR Text Key: 340811772
• Report Number: 1413787-2024-00104
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1414AR
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/21/2024
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1