MAUDE Adverse Event Report: COREGA MAXSEAL; DENTURE ADHESIVE

Lot Number 7X8J

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

Patient Problem Angioedema (4536)

Event Type  Injury  

Manufacturer Narrative

Argus case:(b)(4).

Event Description

I just started to experience quincke's edema [quincke's edema].Had a burning sensation in my mouth, my mouth is still burning.As if i had eaten hot pepper and everything in my mouth was burning [oral discomfort].Allergy started [allergy].I still have some feelings of discomfort [discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of quincke's edema in a 75-year-old female patient who received double salt dental adhesive cream (corega maxseal) cream (batch number 7x8j, expiry date april 2026) for denture failure.Co-suspect products included double salt dental adhesive cream (corega denture adhesive cream) cream (batch number unk, expiry date unknown) for denture failure.Concurrent medical conditions included prosthesis user.Additional patient notes included patient have never had any allergies.On an unknown date, the patient started corega maxseal and corega denture adhesive cream.In (b)(6) 2024, an unknown time after starting corega maxseal and corega denture adhesive cream, the patient experienced quincke's edema (serious criteria haleon medically significant and other: haleon medically signifcant), oral discomfort, allergy and discomfort.The patient was treated with dermatologicals nos (lotion).On an unknown date, the outcome of the quincke's edema and allergy were unknown and the outcome of the oral discomfort and discomfort were not recovered/not resolved.It was unknown if the reporter considered the quincke's edema, oral discomfort, allergy and discomfort to be related to corega maxseal and corega denture adhesive cream.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 received from a consumer via call center representative (voicemail) on 04mar2024.The consumer reported that, "i bought an extra strength core, it's called maximum fixation plus fit.The first time i used it seemed to have no consequences, after using it the second time, i just started to experience quincke's edema.For three days i just had a burning sensation in my mouth.I don't know how i coped with it, but i kept thinking that this was something generally indecent for a person.It was some kind of quiet horror, i only just now realized that it was very dangerous.Even now after a four-day break, my mouth is still burning, but at least i and the milk, i and the water, i cooled it, but i don't know, you need to deal with this drug.Well, it actually costs four hundred rubles, i'm completely outraged and have to ask you directly for some kind of compensation.Well, i'm not a millionaire, i'm a former teacher, i have a pension of thirteen thousand.I am outraged.I know.Call me back.I'll be waiting for your call.Outbound call 04mar2024; 08:16 yes, i will try.I am already 75 years old.Series 7x8j, until apr2026.I wanted to use it only in emergency situations, but it didn't work out.I spent the whole weekend in an emergency situation.Today it's easier, but it was as if i had eaten hot pepper and everything in my mouth was burning.I thought that quincke's edema would begin, but everything turned out okay.I used fermented milk, kept lotions in my mouth and suffered for almost 3 days.I have never had any allergies.This is the side effect that happened.Of course, i feel sorry for those 400 rubles; i receive 13,000 pensions.Of course, i will never buy this brand now, since it's something simpler.I wanted to apply a few drops if i need to go out somewhere.Right now i'm talking to you, and the prosthesis is dangling.If i were nearby, i would directly ask for these 400 rubles upon application with you.I held it, i can't say anything.I didn't find a column that says you can't use it for more than 12 hours, for example.I still have some feelings of discomfort, but at least not like i had for the last 2 days.I won't really say anything anymore.Three days have already passed since my discomfort began.I didn't understand at first.I don't think i ate anything spicy.And it started to burn like after a chili pepper.You take a bite and everything burns in your mouth.And this burning lasted for more than 2 days.I was very scared.There was no swelling, but where the prosthesis was burning in the mouth, it was like a flame.I was scared.I won't use it anymore.When i went to the dentist, they made me this prosthesis, upwards, my husband has the same problem.I brought our corega.At first it was.Well, it's like this in the mouth.He says: well, you will get used to it.And he fell behind once.I say that i brought korega.He smeared it on me, i came home and it stayed with me for almost a day and nothing happened.It was my husband's tube.I bought myself a strong hold.The packaging is so shiny, it inspires confidence.It costs more than 400 rubles.I didn't start using them right away.I started to get used to talking without corega, this and that.Then i had to go to a place where i needed to carry on a conversation and applied as in the instructions, droplets into the bulge and everything was fine.But the allergy started, as i understand it.I'm glad that quincke didn't happen, it didn't happen.And now it's easier for me, i won't use it anymore.I lost money, it hurts me.I will not go anywhere to disgrace myself, despite the fact that the receipt has not been preserved.I thought it would be enough for a long time, at 75 i don't go out often, but oh well.It is necessary to indicate that corega cannot be used for 8 hours, for example.Maybe i overexposed it.The first time everything was great, but then i probably overexposed it.There is something there that the mucous membrane does not accept.It's the delicate skin that reacted this way.This should be a footnote that cannot be overexposed.I still have the sensation, but it has passed.What happened was, i didn't sleep for 2 nights, i got up, took water in my mouth, spit it out and took it in again.And so she walked in the night.And during the day i drank cold kefir and drank apple juice.Ok.As a bonus, you somehow gave me your products.Well, i don't know.And you can't compensate me? ok".The suspect products were reported as corega max seal denture adhesive cream 40g and corega cream unknown variant and size.

• Brand Name: COREGA MAXSEAL
• Type of Device: DENTURE ADHESIVE
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 18910402
• MDR Text Key: 337732086
• Report Number: 3003721894-2024-00035
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 03/04/2024

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: 7X8J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/15/2024
• 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
• Patient Age: 75 YR
• Patient Sex: Female