MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA MAXSEAL; DENTURE ADHESIVE

Lot Number 3E2D

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

Beginning of a stroke [stroke].Can't walk [unable to walk].Pressure rises vertiginously [increased blood pressure].Nauseous [nausea].Sick, ill [sickness].Is completely disoriented [disorientation].Patient was applying the cream 2 to 3 times a day [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of stroke in a 69-year-old male patient who received double salt dental adhesive cream (corega maxseal) cream (batch number 3e2d, expiry date march 2025) for product used for unknown indication.In 2023, the patient started corega maxseal.In 2023, less than an hour after starting corega maxseal, the patient experienced stroke (serious criteria hospitalization and haleon medically significant), unable to walk, increased blood pressure, nausea, sickness and disorientation.The action taken with corega maxseal was unknown.On an unknown date, the outcome of the stroke, unable to walk, increased blood pressure, nausea, sickness and disorientation were unknown.It was unknown if the reporter considered the stroke, unable to walk, nausea, sickness and disorientation to be related to corega maxseal.The reporter considered the increased blood pressure to be related to corega maxseal.This report is made by 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 13jul2023.The consumer reported that "my husband applies the product and not even 10 min later the pressure rises vertiginously.We did not associate with anything and yesterday, by chance he had the pressure at 13/9.After 5/10 min of placing the prosthesis he went to measure the blood pressure and had the pressure at 20.I read and saw that it has sodium in the ingredients, which is salt.Pvm/ma, what does that mean? i will send this product for analysis, because my husband already had the beginning of a stroke, and had to go to hospital because of this crap product.He is always nauseous and sick, because he applies this product and soon after feels ill and the pressure soared.We have already gone to the doctor, the doctors do not see where the issue comes from.Yesterday i did this experiment, measuring the pressure before putting the prosthesis and after a few minutes of application, he already had the pressure at 20.If my husband has a serious problem, you know that i will process the crap of the company because these are not products that you should send out here.This is for free sale it does not require a prescription it does not take anything, free sale on the market or in any pharmacy.I wonder how much sodium you have in this product to rise the pressure vertiginously.These are products that should be well tested and not be sent out to ruin people, you are playing with public health.My husband is here invalid, can't walk, is completely disoriented.You have already done several exams.They do not detect anything.No doctor knows about the problem with corega, because it was only last night that i identified.I can't name the doctors, because of privacy laws and almost always went in the emergency, i don't have the contacts of the doctors who attended him.Started using the product about 3/4 months ago and since then he has been having problems.Batch is 3e2d, expiry is 03/2025.The symptoms began when he started using the product, 3/4 months ago, but we only realized yesterday that it could be that, because his pressure was fine and a few minutes later, the pressure rose and went wrong.Today he did not put the prosthesis and is fine.You can contact me about it.".Follow-up 1 information was received from consumer relations department on 24jul2023.The consumer reported that, "the patient was applying the cream 2 to 3 times a day, because after meals it was taking the prothesis off to wash it".Indication of suspect product updated from 'product used for unknown indication' to 'prosthesis user'.Tto of event 'stroke' updated from 'less than an hour' to 'less than 4 months'.Tto of event 'increased blood pressure' updated to '10 min'.Tto of events unable to walk, nausea and disorientation updated to 'less than 4 months'.Tto of event 'sickness' updated to 'immediately'.Event of 'device used for unapproved schedule' added with verbatim 'patient was applying the cream 2 to 3 times a day', event start date '2023' and causality 'unknown'.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: COREGA MAXSEAL
• 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: 17497990
• MDR Text Key: 320782103
• Report Number: 3003721894-2023-00130
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 07/13/2023

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: 3E2D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/10/2023
• 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: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male