POLIDENT DENTURE CLEANSER TABLETS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-05-23 for POLIDENT DENTURE CLEANSER TABLETS * manufactured by Glaxosmithline, Rtp, Nc.

Event Text Entries

[458425] This case was reported by a consumer and described the occurrence of lymph node cancer in a male patient who received polident (polident denture cleanser tablets) tablet over a period of 8 months for dental cleaning. A physician or other health care professional has not verified this report. The patient's past medical history included tonsils removed. Concurrent medical conditions included enlarged prostate. Concurrent medications included poligrip (super poligrip), calcium citrate (citracal), ascorbic acid (vitamin c), fish oil, finasteride (proscar), tolterodine tartrate (detrol), super b, cyanocobalmin (vitamin b12), glucosamine, duloxetine (cymbalta) and sodium rabeprazole (aciphex). On an unknown date, the patient started polident at 2 tablets. In 2006, during a consult with an ears nose and throat specialist, an enlarged lymph node was discovered on the left side of the neck which was found to be cancerous. The purpose of the initial by the contact by the patient was to ask if polident contained any bleach. He was concerned about "free radicals" because he was told dentures were porous, and asked if his cancerous lymph nodes could be related to the use of polident, because doctors could not explain the source. In the following month, the patient underwent neck dissection of the left side, including removal of part of the jugular vein due to the location of the lymph node. The patient was discharged from the hospital on the 3rd day. Treatment with polident was discontinued. The patient reported subsequent loss of movement in his mouth and residual shoulder numbness related to possible nerve trauma or damge during surgery. The patient was scheduled to begin radiation therapy beginning in 2 months later for a period of six to eight weeks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1020379-2006-00001
• MDR Report Key: 719620
• Report Source: 04
• Date Received: 2006-05-23
• Date of Report: 2006-05-22
• Date Mfgr Received: 2006-05-11
• Date Added to Maude: 2006-05-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: PO BOX 13398
• Manufacturer City: RESEARCH TRIANGLE PARK NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 8888255249
• Manufacturer G1: MEMPHIS FACILITY
• Manufacturer Street: 2149 HARBOR AVENUE
• Manufacturer City: MEMPHIS TN 36113
• Manufacturer Country: US
• Manufacturer Postal Code: 36113
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Generic Name: DENTURE CLEANSER
• Product Code: JER
• Date Received: 2006-05-23
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 708689
• Manufacturer: GLAXOSMITHLINE, RTP, NC
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-05-23