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

Model Number 857R

Device Problem Insufficient Information (3190)

Patient Problem Tooth Fracture (2428)

Event Date 08/23/2022

Event Type  Injury  

Event Description

Consumer stated that he broke his tooth while using the crayola twisted flossers.He had a pre-existing cavity and while using the thick floss, it got wedged-in between his teeth.While trying to remove it from the space between his teeth, it broke and chipped his tooth.

• Brand Name: GUM TWISTABLE 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: 15581885
• MDR Text Key: 301513279
• Report Number: 0001413787-2022-00335
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• 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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 10/11/2022
• 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 Sex: Male