MAUDE Adverse Event Report: C B FLEET CO INC EFFERDENT OVERNIGHT WHITENING; DENTURE CLEANSER

Catalog Number 10814832017351

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

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Initial ((b)(6) 2021): this serious case reported via e-mail refers to a male consumer whose age, medical history, concomitant medications and allergies were not reported.On an unreported date, consumer reported using efferdent overnight whitening tablets to clean his dentures and developed "hot spots" on his gums which later developed into infection.The consumer sought medical attention from an oral surgeon.A biopsy of the gums revealed oral cancer.The company attempted to obtain specific product use information and medical records, however, the consumer refused to offer this information.This case outcome is not recovered/resolved.Meddra version (b)(4): expectedness: lip and/or oral cavity cancer: unexpected.According to the company reference safety information.

• Brand Name: EFFERDENT OVERNIGHT WHITENING
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): C B FLEET CO INC; 4615 murray place; lynchburg VA 24502
• MDR Report Key: 12453412
• MDR Text Key: 272859186
• Report Number: 1719513-2021-01161
• Device Sequence Number: 1
• Product Code: EGT
• 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: 09/10/2021

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 Operator: Lay User/Patient
• Device Catalogue Number: 10814832017351
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/10/2021
• 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