MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. GUM ADVANCED CARE FLOSSER

Model Number 888RXX

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

Patient Problem Tooth Fracture (2428)

Event Date 05/12/2021

Event Type  Injury  

Event Description

My husband's tooth the second time it broke from your product within a couple of days.

• Brand Name: GUM ADVANCED CARE FLOSSER
• Type of Device: FLOSSER
• 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: deanna anderson ; 301 east central road; schaumburg, IL 60195 ; 8477944241
• MDR Report Key: 13029201
• MDR Text Key: 285676716
• Report Number: 0001413787-2021-00015
• 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: 11/22/2021

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: 888RXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Sex: Male