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

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

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Event Description

Aspiration [aspiration].Case description: this case was reported by a consumer via call center representative and described the occurrence of aspiration in a 72-year-old male patient who received double salt dental adhesive cream (new poligrip) cream for denture wearer.The patient's past medical history included asthmatic attack.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip.On an unknown date, an unknown time after starting new poligrip, the patient experienced aspiration (serious criteria gsk medically significant).On an unknown date, the outcome of the aspiration was unknown.It was unknown if the reporter considered the aspiration to be related to new poligrip.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] the patient's past medical history included asthmatic attack.On an unknown date, the patient had been using new poligrip for about 20 years.Recently, he felt like new poligrip melted faster.He hadn't been to the dentist in years since he got dentures.He had lost one of his own teeth, so he was planning to see a dentist soon, so he would ask at that time.On an unknown date, the patient sometimes had aspiration (serious criteria gsk medically significant) about once every 1 to 2 months.The way to deal with it was not that different from when he had an asthma attack when he was in his 20s, so he tried to deal with it without panicking.No further information is expected.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: NEW POLIGRIP
• 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: 15624020
• MDR Text Key: 301904066
• Report Number: 3003721894-2022-00152
• 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: 10/03/2022

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
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/18/2022
• 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 Age: 72 YR
• Patient Sex: Male