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

Model Number 871

Device Problem Break (1069)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Customer purchased one of the ultra tight proxabrush idb's and said the brush is breaking off the wire.

• Brand Name: PROXABRUSH IDB ULTRA TIGHT
• Type of Device: 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: 18073211
• MDR Text Key: 327399723
• Report Number: 1413787-2023-00076
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 00070942002431
• UDI-Public: 00070942002431
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 871
• Device Catalogue Number: RQW
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/16/2023
• Date Manufacturer Received: 10/16/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female