MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM;FLS;DUAL DFNC;3YD;144/BX; FLOSS, DENTAL

Model Number 2008P

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

Patient Problem Tooth Fracture (2428)

Event Date 05/20/2022

Event Type  Injury  

Event Description

Consumer was using a sample of the gum dual floss and while using, she pulled the floss and it pulled a piece of her tooth.

• Brand Name: GUM;FLS;DUAL DFNC;3YD;144/BX
• 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: cynthia culmo ; 301 east central road; schaumburg, IL 60195 ; 8477944241
• MDR Report Key: 14569453
• MDR Text Key: 293294045
• Report Number: 0001413787-2022-00179
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/20/2022

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: 2008P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/01/2022
• 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 Ethnicity: Non Hispanic