MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT DENTURE ADHESIVE MAX SEA

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

Patient Problem Vomiting (2144)

Event Type  Injury  

Event Description

The sticky adhesive cream went over his throat [accidental device ingestion].The adhesive cream would get stuck in his throat [medication stuck in throat].The food would get blocked from it and he would puke for a long time [vomiting].Block his throat [throat tightness].He cannot eat.The food would get blocked from it [unable to eat]would come out sticky with phlegm [phlegm].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 denture adhesive max seal) cream (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.In 2023, the patient started polident denture adhesive max seal.In 2023, an unknown time after starting polident denture adhesive max seal, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: haleon medically significant), medication stuck in throat (serious criteria gsk medically significant), vomiting, throat tightness, unable to eat and phlegm.The action taken with polident denture adhesive max seal was unknown.On an unknown date, the outcome of the accidental device ingestion, medication stuck in throat, vomiting, throat tightness, unable to eat and phlegm were unknown.It was unknown if the reporter considered the accidental device ingestion and phlegm to be related to polident denture adhesive max seal.The reporter considered the medication stuck in throat, vomiting, throat tightness and unable to eat to be related to polident denture adhesive max seal.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information reported by a consumer via call center representative (phone) on 21mar2023.The reporter stated that, "the male consumer did not have issues when he used polident adhesive cream in the past.Doesn't know which product it was.Recently, he was provided with polident max seal from a pharmacy.When he uses it, the adhesive cream would get stuck in his throat.The food would get blocked from it and he would puke for a long time.The max seal product that was left in his mouth would disappear in the morning.He assumes that the max seal went over his throat causing it to block his throat.He cannot eat because his throat is blocked.The sticky adhesive cream went over his throat and would come out sticky with phlegm.Since the company is not being responsible for it, he will report to the consumer center".Follow up information was received on 23mar2023 from quality assurance (qa) department regarding complaint (b)(4) ((b)(4)) for unknown lot number.Follow up information was received on 23mar2023.Product complaint (b)(4) (issue number (b)(4)) was removed as overlogging of pqc complaint.Initial and follow up information processed together.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: POLIDENT DENTURE ADHESIVE MAX SEA
• 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: 16732268
• MDR Text Key: 313214005
• Report Number: 3003721894-2023-00056
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/21/2023

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/13/2023
• 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
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Sex: Male