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

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Event Description

Colon cancer [large intestine carcinoma] lung neoplasm malignant [lung cancer] device colour issue [denture discolouration] case description: this case was reported by a consumer via call center representative and described the occurrence of large intestine carcinoma in a female patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer.Concomitant products included denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009).In (b)(6) 2023, the patient started new poligrip sa.In 2023, an unknown time after starting new poligrip sa, the patient experienced large intestine carcinoma (serious criteria gsk medically significant) and lung cancer (serious criteria gsk medically significant).In (b)(6) 2023, the patient experienced denture discolouration.On an unknown date, the outcome of the large intestine carcinoma, lung cancer and denture discolouration were unknown.It was unknown if the reporter considered the large intestine carcinoma, lung cancer and denture discolouration 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, when the patient was young, she lost teeth by an accident and wore dentures (pink fiber gums with large amount of metal without metal fitting [unknown type of metal]).She used new poligrip sa as a denture cleanser.She hitherto used denture cleansers which were recommended by a dentist.When she used one tablet, many bubbles appeared, and she was worried about the product.In (b)(6) 2023, she used new poligrip sa 75 g.In(b)(6) 2023, when she saw the dentist, the pink gums where new poligrip sa was applied was discolored to white.The dentist could not identify the reason of the discoloration and asked her to visit another dentist.Thereafter, she was worried about using new poligrip and stopped using it.In 2023, metastasis of large intestine carcinoma (seriousness: gsk medically significant) to lung cancer (seriousness: gsk medically significant).She was being examined if metastases to other organs occurred, and repeatedly admitted and discharged from a hospital.No further information is expected.

Manufacturer Narrative

Argus case: (b)(4).

• 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: 18272474
• MDR Text Key: 329775280
• Report Number: 3003721894-2023-00202
• 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: 11/21/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/06/2023
• 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: JAPANESE 5 MINUTE POLIDENT DENTURE CLEANSER TABLET
• Patient Outcome(s): Other
• Patient Sex: Female