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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Foreign body in throat [foreign body in throat].Dysphonia [phonation difficulty].Case description: this case was reported by a non-health professional via call center representative and described the occurrence of foreign body in throat in a patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sa.On an unknown date, an unknown time after starting new poligrip sa, the patient experienced foreign body in throat (serious criteria gsk medically significant) and phonation difficulty.On an unknown date, the outcome of the foreign body in throat and phonation difficulty were unknown.It was unknown if the reporter considered the foreign body in throat and phonation difficulty to be related to new poligrip sa.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, melted cream was stuck in the throat (seriousness: gsk medically significant), and phonation difficulty (seriousness: non-serious) developed.The vendor received a complaint from a customer using new poligrip sa.The customer reportedly experienced the stuck cream in the throat and phonation difficulty.No further information will be provided due to the refusal of the reporting non-health professional.

• Brand Name: NEW POLIGRIP SA
• 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: 18101411
• MDR Text Key: 327729737
• Report Number: 3003721894-2023-00184
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2023

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
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/09/2023
• 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