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

Lot Number UU7X

Device Problem Product Quality Problem (1506)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Fracture [fracture].Device physical property issue [device physical property issue].Case description: this case was reported by a consumer via call center representative and described the occurrence of fracture in a female patient who received double salt dental adhesive cream (new poligrip sa) cream (batch number uu7x, expiry date unknown) for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sa.In 2023, an unknown time after starting new poligrip sa, the patient experienced fracture (serious criteria hospitalization).In (b)(6) 2023, the patient experienced device physical property issue.On an unknown date, the outcome of the fracture and device physical property issue were unknown.It was unknown if the reporter considered the fracture and device physical property issue 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, the patient always used new poligrip sa.Lot number: uu7x in 2023, the patient was admitted to hospital for fracture (serious criteria hospitalization).During the hospitalization, she did not use new poligrip sa.In (b)(6) 2023, the patient was discharged from hospital.When she tried to use her new poligrip sa again, she found the adhesive cream harder than it had been before the hospitalization, and she had to squeeze the tube forcefully to get the adhesive cream out.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: 18037320
• MDR Text Key: 326905098
• Report Number: 3003721894-2023-00178
• 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: 10/13/2023

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
• Device Lot Number: UU7X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female