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

Device Problem Product Quality Problem (1506)

Patient Problems No Code Available (3191); Dry Mouth (4485)

Event Type  Death  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Dry mouth [dryness oral].Death [unknown cause of death].Device difficult to use [device difficult to remove].Case description: this case was reported by a other health professional via call center representative and described the occurrence of unknown cause of death in a patient who received double salt dental adhesive cream (new poligrip sg) cream for denture wearer.Concurrent medical conditions included denture wearer, dementia and living in residential institution.On an unknown date, the patient started new poligrip sg.On an unknown date, an unknown time after starting new poligrip sg, the patient experienced unknown cause of death (serious criteria death and gsk medically significant), dryness oral and device difficult to remove.On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the dryness oral and device difficult to remove were unknown.It was unknown if the reporter considered the unknown cause of death, dryness oral and device difficult to remove to be related to new poligrip sg.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, new poligrip sg had been sold at a shop in the reporting residential institution.New poligrip sg was difficult to remove due to oral dryness (seriousness: non-serious).Two or three male and female patients of the reporting residential institution were using new poligrip sg, and the cream remained in the mouth after using it.Although the patients tried to remove the cream as described in the instruction, it was difficult to remove if the dryness was terrible.The patients using new poligrip sg had dementia.The reporter tried to remove the cream with gauze, but the patients hated it.On an unknown date, the outcome of new poligrip sg was difficult to remove due to oral dryness was unknown.The patient had already passed away.No further information will be provided due to the refusal of the reporting other health professional.

Event Description

Dry mouth [dryness oral].Device difficult to use [device difficult to remove].Case description: this case was reported by a other health professional via call center representative and described the occurrence of unknown cause of death in a patient who received double salt dental adhesive cream (new poligrip sg) cream for denture wearer.Concurrent medical conditions included denture wearer, dementia and living in residential institution.On an unknown date, the patient started new poligrip sg.On an unknown date, an unknown time after starting new poligrip sg, the patient experienced unknown cause of death (serious criteria death and gsk medically significant), dryness oral and device difficult to remove.On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the dryness oral and device difficult to remove were unknown.It was unknown if the reporter considered the unknown cause of death, dryness oral and device difficult to remove to be related to new poligrip sg.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, new poligrip sg had been sold at a shop in the reporting residential institution.New poligrip sg was difficult to remove due to oral dryness (seriousness: non-serious).Two or three male and female patients of the reporting residential institution were using new poligrip sg, and the cream remained in the mouth after using it.Although the patients tried to remove the cream as described in the instruction, it was difficult to remove if the dryness was terrible.The patients using new poligrip sg had dementia.The reporter tried to remove the cream with gauze, but the patients hated it.On an unknown date, the outcome of new poligrip sg was difficult to remove due to oral dryness was unknown.The patient had already passed away.This report is being resubmitted to capture corrections.The information was received on 11-dec-2020.Death was deleted.No further information will be provided due to the refusal of the reporting other health professional.Downgrade report.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: NEW POLIGRIP SG
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 10566402
• MDR Text Key: 207916024
• Report Number: 3003721894-2020-00248
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other