MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM CRAYOLA POWERED TOOTHBRUSH; TOOTHBRUSH, POWERED

Model Number 2272RC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2019

Event Type  malfunction  

Event Description

Consumer bought the gum crayola toothbrush and the daughter stated when she was using the toothbrush, the bristles got stuck in her teeth and separated from the toothbrush.

Manufacturer Narrative

This mdr report is generated retrospectively based on complaints audit.

• Brand Name: GUM CRAYOLA POWERED TOOTHBRUSH
• Type of Device: TOOTHBRUSH, POWERED
• 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: 15243661
• MDR Text Key: 298208874
• Report Number: 0001413787-2022-00310
• Device Sequence Number: 1
• Product Code: JEQ
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 2272RC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 08/17/2022
• 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