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

Model Number 614PA

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

Consumer was using the idb proxabrush and the wire bent and broke easily.

• Brand Name: IDB PROXABRUSH
• 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: monica jadczak ; 301 east central road; schaumburg, IL 60195 ; 8477944229
• MDR Report Key: 15254776
• MDR Text Key: 298209530
• Report Number: 0001413787-2022-00316
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 614PA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No
• 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