MAUDE Adverse Event Report: GLAXOSMITHKLINE POLIGRIP; DENTURE ADHESIVE

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

Patient Problems Tingling (2171); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report # is associated with argus case (b)(4).

Event Description

Cardiac steatosis [cardiac steatosis], paraesthesia [tingling sensation].This case was reported by a consumer via call center representative and described the occurrence of cardiac steatosis in a female patient who received double salt dental adhesive cream (poligrip) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started poligrip.On an unknown date, an unknown time after starting poligrip, the patient experienced cardiac steatosis (serious criteria gsk medically significant).On an unknown date, an unknown time after starting poligrip, the patient experienced tingling sensation.On an unknown date, the outcome of the cardiac steatosis and tingling sensation were unknown.It was unknown if the reporter considered the cardiac steatosis and tingling sensation to be related to poligrip.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the patient used poligrip and swallowed it.When she underwent electrocardiography, she was pointed out fat around the heart; she took exercise, but the fat was not decreased.When she twisted her body, she felt a tingling sensation.No further information is expected.

• Brand Name: POLIGRIP
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE; dungarvan ltd; dungarvan; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle parl; 8888255249
• MDR Report Key: 8448345
• MDR Text Key: 139739816
• Report Number: 3003721894-2019-00063
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

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: No Information
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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