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

Lot Number MM2U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(6).

Event Description

Long time, was swallowed and got attached on throat or not [accidental device ingestion].Got attached on throat [medication stuck in throat].Voice became hoarse [hoarse voice].Felt like swallowing saliva and sticky in mouth [oral discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of hoarse voice in a patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced hoarse voice and oral discomfort.On an unknown date, the outcome of the hoarse voice and oral discomfort were unknown.It was unknown if the reporter considered the hoarse voice and oral discomfort to be related to polident denture adhesive cream.Additional details: initial and follow up processed together the consumer reported consumer was denture adhesive cream user, it had been 7 years till now since consumer used product from this june, consumer had some issues.Consumer felt issues.From (b)(6) on, consumer felt voice became hoarse (not yet consulted doctor now), planned to consult recently, not sured whether it was because adhesive cream dissolved in mouth for long time and was swallowed and attached on throat.Affected the operation of the vocal cords and resulted in hoarseness.Whether it was normal if feeling swallowing saliva and sticky.Adhesive cream was purchased at xingyi pharmacy or via online purchase.May consumer knew the valid duration of product.Was there requirement for storing temperature.Follow up information received on 25 jul 2020: no new information received.Follow up information received via consumer on 30 jul 2020: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number mm2u, expiry date april 2022) for denture wearer.Concurrent medical conditions included diabetes.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant), medication stuck in throat (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion, medication stuck in throat were unknown.It was unknown if the reporter considered the accidental device ingestion, medication stuck in throat to be related to polident denture adhesive cream.Caller said still wanted to ask about voice became hoarseness, whether that was because adhesive cream was dissolved in mouth for long time, was swallowed and got attached on throat or not.Caller provided product information photos.Caller had not yet consulted doctor.Caller had diabetes, all consumer ate was very simple.

• Brand Name: POLIDENT 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: 10436491
• MDR Text Key: 208132034
• Report Number: 3003721894-2020-00227
• 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: 07/25/2020

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: Lay User/Patient
• Device Lot Number: MM2U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/21/2020
• 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): Other