MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SG; DENTURE ADHESIVE

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

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Event Description

Arrhythmia [arrhythmia].Case description: this case was reported by a dentist via call center representative and described the occurrence of arrhythmia in a elderly male patient who received double salt dental adhesive cream (new poligrip sg) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sg.On an unknown date, an unknown time after starting new poligrip sg, the patient experienced arrhythmia (serious criteria gsk medically significant).On an unknown date, the outcome of the arrhythmia was unknown.It was unknown if the reporter considered the arrhythmia to be related to new poligrip sg.This report is made by gsk/hale on without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, the reporter was a dentist and also a user of new poligrip sg.The patient, who was a friend of the reporter's and an internist, said to the reporter that he experienced arrhythmia (serious criteria gsk medically significant) when using new poligrip sg and asked the reporter if new poligrip sg could cause such a symptom.[reporter's comment] the package insert listed all the ingredients of new poligrip sg, and they were basically minty ingredients, and hence, it was considered quite unlikely that the product might have an impact on the heart.No further information will be provided due to the refusal of the reporting dentist.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: NEW POLIGRIP SG
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15930692
• MDR Text Key: 304957759
• Report Number: 3003721894-2022-00195
• 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: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/07/2022
• 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
• Patient Sex: Male