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

Model Number 859R

Device Problem Insufficient Information (3190)

Patient Problem Tooth Fracture (2428)

Event Date 09/19/2022

Event Type  Injury  

Event Description

Consumer stated his son was using the kids gum twisted flossers and it broke part of his tooth.He used it again and broke more of the same tooth.

• Brand Name: GUM KIDS 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: 15509347
• MDR Text Key: 300883703
• Report Number: 0001413787-2022-00329
• 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: 09/19/2022

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?: Yes
• Device Model Number: 859R
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 09/30/2022
• 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