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

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

Patient Problem Stomach Ulceration (4488)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Gastric ulcer.This case was reported by a consumer via call center representative and described the occurrence of gastric ulcer in a 91-year-old male patient who received double salt dental adhesive cream (new poligrip) cream for denture wearer.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 gastric ulcer (serious criteria gsk medically significant and other).On an unknown date, the outcome of the gastric ulcer was not recovered/not resolved.It was unknown if the reporter considered the gastric ulcer to be related to new poligrip.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course]: on an unknown date, the patient had used new poligrip for a long time.He recently experienced gastric ulcer (serious criteria gsk medically significant and other: requiring treatment for more than 30 days) and was receiving treatment.On an unknown date, the patient had received treatment for 2 months.Even though he did not drink alcohol or take any stimulant, it was still not resolved.He would stop using.No further information is expected.

• 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: 15192962
• MDR Text Key: 297534276
• Report Number: 3003721894-2022-00110
• 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: 07/13/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/09/2022
• 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: 91 YR
• Patient Sex: Male