MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD ULTRA COREGA CREAM WITHOUT FLAVOUR; DENTURE ADHESIVE

Lot Number B25E

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

Patient Problem Hypervolemia (2664)

Event Date 04/11/2023

Event Type  Injury  

Event Description

But i went to drink water and suffered a horrible choking [choke on medication].Ended up swallowing [accidental device ingestion].I couldn't breathe [difficulty breathing].I was even nervous [nervous].Case description: this case was reported by a consumer via call center representative and described the occurrence of choke on medication in a 52-year-old female patient who received double salt dental adhesive cream (ultra corega cream without flavour) cream (batch number b25e, expiry date 30th november 2025) for denture failure.Concurrent medical conditions included prosthesis user.On (b)(6) 2023, the patient started ultra corega cream without flavour.On (b)(6) 2023, less than a day after starting ultra corega cream without flavour, the patient experienced choke on medication (serious criteria gsk medically significant and other: haleon medically significant), accidental device ingestion (serious criteria gsk medically significant), difficulty breathing and nervous.The action taken with ultra corega cream without flavour was unknown.In (b)(6) 2023, the outcome of the choke on medication, accidental device ingestion and nervous were recovered/resolved.On an unknown date, the outcome of the difficulty breathing was unknown.The reporter considered the choke on medication to be related to ultra corega cream without flavour.It was unknown if the reporter considered the accidental device ingestion, difficulty breathing and nervous to be related to ultra corega cream without flavour.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:the adverse event information was received from consumer via call center representative (phone) on (b)(6) 2023 and consumer reported that "i got that number on the internet i wanted some advice from you guys.I suffered an accident like this.I use prosthesis but i don't always use the corega,i only use it for the lower part.The dentist said it would be recommended to have an implant, but i didn't.I'm 52 years old, i'm obligated to use corega on the top.I use it and it gets normal, i talk to him and everything.But i went to drink water and suffered a horrible choking,i ended up swallowing that little goo and the person who was with me had to help me in a hurry was crazy.I was even nervous, i couldn't breathe right.So i wanted to know if swallowing this gum can cause this possibility of choking.This happened when i was drinking water.Because i no longer use it if the answer is yes.I don't use corega much, only when i'm going to leave".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: ULTRA COREGA CREAM WITHOUT FLAVOUR
• 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: 16901617
• MDR Text Key: 314894374
• Report Number: 3003721894-2023-00072
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/11/2023

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
• Device Lot Number: B25E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/10/2023
• 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 Age: 52 YR
• Patient Sex: Female