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

Model Number 535P

Device Problem Break (1069)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

Consumer stated they purchased a 3 pack of gum toothbrushes and all 3 handles broke in 2 while brushing their teeth.

• Brand Name: GUM DAILY 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 AMERICA'S INC; 301 east central road; schaumburg IL 60195
• Manufacturer Contact: paula wendland ; 301 east central road; schaumburg, IL 60195 ; 8477944134
• MDR Report Key: 18154509
• MDR Text Key: 329350979
• Report Number: 1413787-2023-00078
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 535P
• Device Lot Number: 1032S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/19/2023
• Date Manufacturer Received: 10/19/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male