MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. FLOSS WAX; MINT; TOOTHBRUSH, MANUA

Model Number 1910RA

Device Problem Insufficient Information (3190)

Patient Problem Tooth Fracture (2428)

Event Date 11/10/2022

Event Type  Injury  

Event Description

A consumer called to say she had used some floss and while using the floss, it pulled part of her teeth, breaking part of her tooth off.

• Brand Name: FLOSS WAX; MINT
• Type of Device: TOOTHBRUSH, MANUA
• 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: 16517951
• MDR Text Key: 311036729
• Report Number: 0001413787-2023-00017
• 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: 03/09/2023

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: 1910RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/09/2023
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic