POLIDENT DENTURE ADHESIVE CREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-28 for POLIDENT DENTURE ADHESIVE CREAM manufactured by Glaxosmithkline Dungarvan Ltd.

Event Text Entries

[28599159] Accidental ingestion of product [accidental device ingestion]. Incorrect use of product [device misuse]. Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer. Concurrent medical conditions included benign prostatic hyperplasia. Since the beginning of (b)(6) 2015, the patient started polident denture adhesive cream. In (b)(6) 2015, an unknown time after starting polident denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and device misuse. On an unknown date, the outcome of the accidental device ingestion and device misuse were unknown. Additional information: the patient has used polident denture adhesive cream twice a day, once before breakfast and once before lunch. The patient reported the product melted when he consumes hot liquids, that he has swallowed the product since the beginning of (b)(6) 2015. The patient spoke to his dentist and asked if swallowing the product would be harmful and the dentist commented that the product wouldn't melt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003721894-2015-00012
• MDR Report Key: 5145112
• Date Received: 2015-09-28
• Date of Report: 2015-09-18
• Date of Event: 2015-08-01
• Date Mfgr Received: 2015-09-18
• Date Added to Maude: 2015-10-13
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: PO BOX 13398
• Manufacturer City: RESEARCH TRIANGLE PARK NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 8888255249
• Manufacturer G1: GSK
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Generic Name: DENTURE ADHESIVE
• Product Code: KOL
• Date Received: 2015-09-28
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GLAXOSMITHKLINE DUNGARVAN LTD
• Manufacturer Address: DUNGARVAN, WATERFORD EI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-09-28