MAUDE Adverse Event Report: COREGA TRIPLE ACTION CREAM; DENTURE ADHESIVE

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2024

Event Type  Injury  

Event Description

I'm intoxicated [intoxication].Itchy all over [generalized pruritus].It started to make me feel sick [feeling unwell].Transparent gunk looking like phlegm [ill-defined disorder].Case description: this case was reported by a consumer via call center representative and described the occurrence of intoxication in a male patient who received double salt dental adhesive cream (corega max block) cream (batch number unk, expiry date unknown) for denture wearer.Co-suspect products included double salt dental adhesive cream (corega triple action cream) cream (batch number unk, expiry date unknown) for denture wearer and double salt dental adhesive cream (ultra corega cream without flavour) cream (batch number unk, expiry date unknown) for denture wearer.On an unknown date, the patient started corega max block, corega triple action cream and ultra corega cream without flavour.On (b)(6) 2024, an unknown time after starting corega max block, corega triple action cream and ultra corega cream without flavour, the patient experienced intoxication (serious criteria haleon medically significant and other: haleon medically signifcant) and generalized pruritus.On an unknown date, the patient experienced feeling unwell and ill-defined disorder.The action taken with corega max block was unknown.The action taken with corega triple action cream was unknown.The action taken with ultra corega cream without flavour was unknown.On an unknown date, the outcome of the intoxication, generalized pruritus, feeling unwell and ill-defined disorder were unknown.It was unknown if the reporter considered the intoxication, generalized pruritus and ill-defined disorder to be related to corega max block, corega triple action cream and ultra corega cream without flavour.The reporter considered the feeling unwell to be related to corega max block, corega triple action cream and ultra corega cream without flavour.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 a consumer via call center representative (phone) on 04mar2024.The consumer reported that, "i use corega and i have temporary dentures, i'm intoxicated and itchy all over, i looked at the packaging and it said that certain events can happen.Should i see a doctor or drink milk to relieve it? i bought 3 corega's: tripla acao 20g, one menta and unflavored, max fixacao + bloqueio 40g.It started to make me feel sick, a transparent gunk looking like phlegm and the day before yesterday it started to make me itch, i stopped using it.I'm going to the doctor and tomorrow i'll call with the news, i don't understand what this is, i need to go to the city and see the doctor quickly".

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: COREGA TRIPLE ACTION CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 18927751
• MDR Text Key: 337946426
• Report Number: 3003721894-2024-00033
• 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: 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/19/2024
• 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 Sex: Male