MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. ADVANCED CARE FLOSSERS; FLOSS, DENTAL

Model Number 888BC

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

Patient Problem Tooth Fracture (2428)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

This mdr report is generated retrospectively based on complaints audit.

Event Description

Consumer called to say they used the advanced care flossers and it damaged their tooth.Dentist sent along a letter confirming the tooth was cracked.

• Brand Name: ADVANCED CARE 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: 15179504
• MDR Text Key: 297410311
• Report Number: 0001413787-2022-00283
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2021

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: 888BC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 08/05/2022
• 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