MAUDE Adverse Event Report: SUNSTAR AMERICA'S INC. GUM TECHNIQUE DEEP CLEAN TOOTHBRUSH; TOOTHBRUSH, MANUAL

Model Number 525

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

A consumer called and reported a complaint on (b)(6) 2023.She stated that she had got two free toothbrushes from the dentist.The toothbrushes she had recieved were the gum technique deep clean brushes.She stated that on one of the two brushes, bristles were falling off of the toothbrush.

• Brand Name: GUM TECHNIQUE DEEP CLEAN TOOTHBRUSH
• 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: 18498420
• MDR Text Key: 332903233
• Report Number: 1413787-2024-00087
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 525
• Device Catalogue Number: D
• Device Lot Number: P19012
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/13/2023
• Date Manufacturer Received: 12/13/2023
• 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
• Patient Sex: Female