MAUDE Adverse Event Report: C B FLEET CO INC DENTEK TRIPLE CLEAN FLOSS PICKS, MOUTHWASH BLAST; DENTAL FLOSS

Catalog Number 00027007203Q

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Initial ((b)(6) 2021): this serious case reported via e-mail refers to a male consumer who was flossing his teeth with a dentek triple clean floss pick that broke during use.Consumer reported "using my floss pick to get something out from the back/side of my wisdom tooth when the pick part just broke off in my mouth and got stuck in my throat! i felt it go deeper and started to choke me.I was scared and fell to my hands and knees and somehow this thing moved back toward my mouth." consumer did not seek medical attention and stopped use of the floss picks.The consumer sent pictures of the packaging as well as pictures of the broken floss pick.The company requested the product back from the consumer, but has not yet been returned.Meddra version 24.0.Expectedness: foreign body in throat: unexpected.Device breakage: unexpected.According to the company reference safety information.Arisg number: (b)(4).

• Brand Name: DENTEK TRIPLE CLEAN FLOSS PICKS, MOUTHWASH BLAST
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): C B FLEET CO INC; 4615 murray place; lynchburg VA 24502
• MDR Report Key: 12131778
• MDR Text Key: 263399731
• Report Number: 1719513-2021-00918
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 00027007203Q
• Device Lot Number: 1904AC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other