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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

It was as if there were grains of something [in her mouth] which would feel ["hard"] (that is, gulping or choking) [choking sensation].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking sensation in a (b)(6) year-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.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 choking sensation (serious criteria gsk medically significant and other: gsk medically significant).The action taken with polident denture adhesive cream was unknown.On an unknown date, the outcome of the choking sensation was unknown.It was unknown if the reporter considered the choking sensation to be related to polident 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- this case was reported via call center representative on 12-may-2021.The consumer stated that, " when removing her dentures in the evening, the consumer would find it difficult to remove the adhesive cream, which would stick to her mouth.It was as if there were grains of something [in her mouth], which would feel ["hard"] (that is, gulping or choking).

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: research triangle park; po box 13398; 8888255249
• MDR Report Key: 11941654
• MDR Text Key: 267305975
• Report Number: 3003721894-2021-00182
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• 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
• Patient Age: 88 YR