MAUDE Adverse Event Report: SUNSTAR AMERICA'S INC. PROXABRUSH IDB REFILLS; TOOTHBRUSH, MANUAL

Model Number 614PA

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

Consumer stated they were using the idb refils and this time she was using it and it got stuck and she had to use tweezers to get it out.She said it broke at the wire.

• Brand Name: PROXABRUSH IDB REFILLS
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICA'S 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: 18073135
• MDR Text Key: 327398726
• Report Number: 1413787-2023-00075
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 614PA
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/11/2023
• Date Manufacturer Received: 10/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female