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

Lot Number RL4W

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Hold sl 12-22-2022.I almost died choking [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a female patient who received double salt dental adhesive cream (corega ultra cream without flavor) cream (batch number: rl4w, expiry date: 31st august 2024) for denture failure.This case was associated with a product complaint.Co-suspect products included denture adhesive powder-double salt (corega powder) oral powder (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started corega ultra cream without flavor and corega powder.On (b)(6) 2022, an unknown time after starting corega ultra cream without flavor and corega powder, the patient experienced choking (serious criteria gsk medically significant).On an unknown date, the patient experienced product complaint.The action taken with corega ultra cream without flavor was unknown.On an unknown date, the outcome of the choking and product complaint were unknown.It was unknown if the reporter considered the choking to be related to corega ultra cream without flavor and corega powder.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 was received from consumer via call center representative (phone) on 29nov2022.It was reported that "i bought two corega products and it's not helping at all.I almost died choking yesterday because it don't fix it, where have you seen this.I just want my money back, they told me it was good.It's an expensive product and this happens.I bought corega ultra and corega powder." this is 1 of 2 cases reported by same reporter.Case (b)(4) and case (b)(4) are linked because of same reporter and patient details.

• Brand Name: COREGA ULTRA CREAM WITHOUT FLAVOR
• 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: 16034161
• MDR Text Key: 306000992
• Report Number: 3003721894-2022-00201
• 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: 11/29/2022

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: RL4W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/22/2022
• 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: Female