MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM CRAYOLA TWISTED FLOSSERS; FLOSS, DENTAL

Model Number 857R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 08/23/2022

Event Type  Injury  

Event Description

Consumer stated he broke his tooth using the crayola twisted flossers.He stated while using it, the floss got wedged between his teeth and while trying to remove the floss, it broke and chipped his tooth.

• Brand Name: GUM CRAYOLA TWISTED FLOSSERS
• Type of Device: FLOSS, DENTAL
• 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: 15327477
• MDR Text Key: 298969673
• Report Number: 0001413787-2022-00320
• Device Sequence Number: 1
• Product Code: JES
• 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: 08/23/2022

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?: No
• Device Model Number: 857R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 08/31/2022
• 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 Outcome(s): Other
• Patient Sex: Male