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

[28599442] Device dependence [dependence]. Possible device ingestion [accidental device ingestion]. Case description: this case was reported by a consumer via call center representative and described the occurrence of dependence in a female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer. Additional patient notes included she had no allergy or other disease history. In 2013, the patient started polident denture adhesive cream. On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced dependence (serious criteria gsk medically significant) and accidental device ingestion (serious criteria gsk medically significant). On an unknown date, the outcome of the dependence was not recovered/not resolved and the outcome of the accidental device ingestion was unknown. It was unknown if the reporter considered the dependence and accidental device ingestion to be related to polident denture adhesive cream. Additional information: the consumer used polident cream for one or two years (around 2013). The patient used it before each meal (3 times daily) because she felt the cream was washed away after meal. The patient dared not to eat food if not using the cream, and felt that she developed dependence on it. The patient had cancer screen and confirmed no cancer disease a few days ago.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003721894-2015-00011
• MDR Report Key: 5145103
• Date Received: 2015-09-28
• Date of Report: 2015-09-16
• Date Mfgr Received: 2015-09-16
• 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
• Operator: LAY USER/PATIENT
• Device Availability: *
• 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