MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT FREE DENTURE ADHESIVE CREAM

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Sore Throat (2396)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

As the adhesive cream melted, it was swallowed [accidental device ingestion] sore throat, pain in throat is severe [sore throat].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident free denture adhesive cream) cream (batch number unknown, expiry date unknown) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started polident free denture adhesive cream.On an unknown date, an unknown time after starting polident free denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), sore throat and product complaint.The action taken with polident free denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion, sore throat and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and sore throat to be related to polident free denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: it was reported that polident free denture adhesive cream had been used to attach the denture.As the adhesive cream melted, it was swallowed, and it resulted in sore throat.It was said that the pain in the throat was severe.When visited private hospital, (the consumer) was referred to the big hospital.Concurrent disease/ concomitant medications were unknown.Consumer treated by an hcp none.Polident denture adhesive cream 70 g.Follow up information was received on 4 january 2021 via quality assurance department regarding product complaint (b)(4) (lot number unknown).No sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information was not available the complaint could not be substantiated.All of the documentation pertinent to a specific lot of finished product was contained in a [?]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope was reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verified that all test results meet specification requirements.This complaint was concluded as unsubstantiated.

• Brand Name: POLIDENT FREE DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 11154027
• MDR Text Key: 230236809
• Report Number: 3003721894-2020-00390
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 12/21/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: No
• 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