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

Catalog Number 00008107206Q

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Initial ((b)(6) 2021): this reportable incident received via e-mail refers to a male consumer who used the dentek triple clean floss picks for teeth flossing.On an unreported date, the consumer attempted to use the device when the tip of the floss pick broke and he reported the tip was accidentally swallowed.The consumer reported the same device malfunction has occurred during prior uses of this product.No injuries were reported.The company obtained photos of the broken device from the consumer.Meddra version 24.0.Expectedness: device breakage: unexpected.Accidental device ingestion: unexpected.

• 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: 12182847
• MDR Text Key: 263400013
• Report Number: 1719513-2021-00975
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 00008107206Q
• Device Lot Number: 2007AA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2021
• Initial Date FDA Received: 07/16/2021
• 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