MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM CRAYOLA TOOTHBRUSH, MARKER, METALLIC; TOOTHBRUSH, MANUAL

Model Number 227KKM

Device Problem Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

I bought a double pack of children's crayola toothbrushes.My granddaughter who is 3 brushed her teeth and a bristle from the toothbrush got stuck in her tooth.I got it out but i don't think this should have happened.It was maybe 1/2 inch long in a u shape.

Manufacturer Narrative

The corrections to the original mdr submitted are as follows: 1.Section b.1.- added adverse event.2.Section b.3.- added date of event - 04/22/2021.3.Section b.4.- corrected date of report - 04/23/2021.4.Section g.3.- added date recieved y manufacturer - 04/23/2021.5.Section g.7.- added adverse event terms - bristles stuck between tooth.6.Section h.6.- added adverse problem codes - 3165, 4613.

Event Description

I bought a double pack of children's crayola toothbrushes.My granddaughter who is 3 brushed her teeth and a bristle from the toothbrush got stuck in her tooth.I got it out but i don't think this should have happened.It was maybe 1/2 inch long in a u shape.

• Brand Name: GUM CRAYOLA TOOTHBRUSH, MARKER, METALLIC
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): SUNSTAR AMERICAS INC.; 301 e. central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS INC.; 301 e. central road; schaumburg IL 60195
• Manufacturer Contact: cristina tatoiu ; 301 e. central road; schaumburg, IL 60195 ; 8477944223
• MDR Report Key: 11893692
• MDR Text Key: 265170497
• Report Number: 0001413787-2021-00008
• 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,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 227KKM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2021
• 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 Age: 3 YR
• Patient Sex: Female