MAUDE Adverse Event Report: SUNSTAR INC GUM TECHNIQUE DEEP CLEAN TOOTHBRUSH; MANUAL TOOTHBRUSH

Model Number 525PHS

Device Problem Material Separation (1562)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

Customer contacted sunstar on (b)(6) 2024 regarding the gum® technique® deep clean toothbrush, compact with soft bristles product.Upon use, the toothbrush has been losing its bristles in the users mouth.To remove they had to swish and gargle (with an oral rinse) to remove from tonsil or use floss and an interdental or a tweezer if it is caught between their teeth.No injury was reported.

• Brand Name: GUM TECHNIQUE DEEP CLEAN TOOTHBRUSH
• Type of Device: MANUAL TOOTHBRUSH
• Manufacturer (Section D): SUNSTAR INC; 301 e. central rd; schaumburg 60195
• Manufacturer Contact: paula wendland ; 301 e. central; schaumburg, IL 60195 ; 7733554024
• MDR Report Key: 18762833
• MDR Text Key: 336080465
• Report Number: 1413787-2024-00097
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 525PHS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/29/2024
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1