MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM DEEP CLEAN TOOTHBRUSH

Model Number 524KM

Device Problem Break (1069)

Patient Problem Choking (2464)

Event Date 05/07/2019

Event Type  Injury  

Event Description

I have a child of (b)(6) years old that today almost lost by the toothbrush that you distribute.I still tremble to remember how my son was drowning and unable to do anything because the brush broke while he brushed his tongue and stayed in his throat.

Event Description

I have a child of (b)(6) years old that today almost lost by the toothbrush that you distribute.I still tremble to remember how my son was drowning and unable to do anything because the brush broke while he brushed his tongue and stayed in his throat.

• Brand Name: GUM DEEP CLEAN TOOTHBRUSH
• Type of Device: TOOTHBRUSH
• 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: deanna anderson ; 301 east central road; schaumburg, IL 60195 ; 8477944241
• MDR Report Key: 13047892
• MDR Text Key: 285676837
• Report Number: 0001413787-2021-00017
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 524KM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic