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].Dyspnoea [dyspnoea].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a female patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer and surgery.Concomitant products included double salt dental adhesive cream (new poligrip).On an unknown date, the patient started new poligrip sa.On an unknown date, an unknown time after starting new poligrip sa and new poligrip, the patient experienced foreign body in throat (serious criteria gsk medically significant) and dyspnoea.On an unknown date, the outcome of the foreign body in throat and dyspnoea were unknown.It was unknown if the reporter considered the foreign body in throat and dyspnoea 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] concurrent medical conditions included throat surgery.On an unknown date, 10 years had passed since the patient had to get dentures.She forgot that she had used new poligrip before and had disliked feeling in use very much, so she purchased and used new poligrip sa again.Although she just applied a negligible amount to 3 sites of the hollow area of the upper denture, the adhesive that run into the mouth and throat stuck on there and could not be removed after removing the denture (serious criteria gsk medically significant).In addition, she had difficulty breathing (serious criteria non-serious) because the amount of the adhesive was a lot and she could not swallow it.The adhesive could not be removed at all even though she rubbed with a toothbrush for brushing the dentures.She vomited and that was very tough.She was really worried when something like this happened because she had undergone throat surgery before.She wore the denture using new poligrip before lunch and removed the denture soon after lunch, so she removed the denture after a short time.She did not feel like the adhesive had been completely removed.No further information is expected.

• 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: 18037279
• MDR Text Key: 326911658
• Report Number: 3003721894-2023-00176
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2023

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: 10/12/2023
• Initial Date FDA Received: 10/31/2023
• 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
• Treatment: NEW POLIGRIP (DOUBLE SALT DENTAL ADHESIVE CREAM).
• Patient Outcome(s): Other
• Patient Sex: Female