MAUDE Adverse Event Report: SUNSTAR AMERICA'S INC. GUM PRO-WEAVE DENTAL FLOSS; FLOSS, DENTAL

Model Number 1840

Device Problem Insufficient Information (3190)

Patient Problem Tooth Fracture (2428)

Event Date 12/27/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 a consumer said she just bought floss from costco and used it for the first time.She got the floss between her two teeth, but had trouble getting it out.She stated that she chipped part of her tooth during use of the floss.

• Brand Name: GUM PRO-WEAVE DENTAL FLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): SUNSTAR AMERICA'S INC.; 301 east central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS INC.; 301 east central road; schaumburg IL 60195
• Manufacturer Contact: paula wendland ; 301 east central road; schaumburg, IL 60195 ; 7733554024
• MDR Report Key: 18614641
• MDR Text Key: 334214367
• Report Number: 1413787-2024-00091
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2024

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 Operator: Lay User/Patient
• Device Model Number: 1840
• Device Catalogue Number: RN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/03/2024
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female