MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM MONSTERZ TOOTHBRUSH; TOOTHBRUSH, MANUAL

Model Number 901A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Choking (2464)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

This mdr report is generated retrospectively based on complaints audit.

Event Description

Consumer bought a gum toothbrush for her one and a half year old daughter and she choked on the loose bristles.

• Brand Name: GUM MONSTERZ TOOTHBRUSH
• 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: 15240098
• MDR Text Key: 298040081
• Report Number: 0001413787-2022-00302
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 901A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• 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 Outcome(s): Other
• Patient Age: 18 MO
• Patient Sex: Female