MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SA2; DENTURE ADHESIVE

Lot Number 7U4D

Device Problem Product Quality Problem (1506)

Patient Problem Hernia (2240)

Event Type  Injury  

Event Description

Hernia: product physical: issue product clumping.Product container issue: product container issue.Case description: this case was reported by a consumer via call center representative and described the occurrence of hernia in a female patient who received double salt dental adhesive cream (new poligrip sa2) cream for denture wearer.Concurrent medical conditions included denture wearer.In (b)(6) 2022, the patient started new poligrip sa2.On an unknown date, an unknown time after starting new poligrip sa2, the patient experienced hernia (serious criteria hospitalization), product clumping and product container issue.On an unknown date, the outcome of the hernia, product clumping and product container issue were unknown.It was unknown if the reporter considered the hernia, product clumping and product container issue to be related to new poligrip sa2.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: in (b)(6) 2022, the patient bought new poligrip sa2 (70 g) at shop b in a.On an unknown date, as the adhesive cream at the tip of the nozzle hardened, it became hard to squeeze the tube, and the tube eventually got a 2-cm torn near the nozzle.She had had no problems when using a small-sized new poligrip sa2.She was scheduled to be hospitalised for hernia (serious criteria hospitalization) for about 3 months.

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of hernia in a female patient who received double salt dental adhesive cream (new poligrip sa2) cream for denture wearer.Concurrent medical conditions included denture wearer.In (b)(6) 2022, the patient started new poligrip sa2.On an unknown date, an unknown time after starting new poligrip sa2, the patient experienced hernia (serious criteria hospitalization), product clumping and product container issue.On an unknown date, the outcome of the hernia, product clumping and product container issue were unknown.It was unknown if the reporter considered the hernia, product clumping and product container issue to be related to new poligrip sa2.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] in (b)(6) 2022, the patient bought new poligrip sa2 (70 g) at shop b in a.On an unknown date, as the adhesive cream at the tip of the nozzle hardened, it became hard to squeeze the tube, and the tube eventually got a 2-cm torn near the nozzle.She had no problems when using a small-sized new poligrip sa2.She was scheduled to be hospitalised for hernia (serious criteria hospitalization) for about 3 months.Follow-up information received from the reporting consumer on 27-jan-2023 [clinical course] on an unknown date, the patient was admitted to a hospital for hernia and was discharged.On 27th january 2023, the product was received.Lot #: 7u4d.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: NEW POLIGRIP SA2
• 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: 16059607
• MDR Text Key: 306245111
• Report Number: 3003721894-2022-00205
• 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,Followup
• Report Date: 12/01/2022

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?: Yes
• Device Lot Number: 7U4D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/21/2023
• 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