MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA DENTURE CLEANSING TABLETS; DENTURE CLEANSER

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

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

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I had a reaction and almost lost consciousness [consciousness disturbed] case description: this case was reported by a consumer via call center representative and described the occurrence of consciousness disturbed in a female patient who received denture cleanser (corega denture cleansing tablets) tablet (batch number unk, expiry date unknown) for denture wearer.Concurrent medical conditions included allergy (to smells, to essential oils, to minty smells, in general to anything harsh).On an unknown date, the patient started corega denture cleansing tablets.On an unknown date, an unknown time after starting corega denture cleansing tablets, the patient experienced consciousness disturbed (serious criteria haleon medically significant).The action taken with corega denture cleansing tablets was unknown.On an unknown date, the outcome of the consciousness disturbed was unknown.It was unknown if the reporter considered the consciousness disturbed to be related to corega denture cleansing tablets.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 18dec2023.The consumer reported that,"i am allergic to smells, to essential oils, to minty smells, in general to anything harsh.I use dentures and corega cream.There is a neutral taste cream, i use it.Please tell me, are there any tablets for cleansing dentures without fragrances, without mint, without menthol? or some formula containing a bare minimum of this smell, in any form.Corega tablets.There are 3 types of them: dental white, bio formula and double strength.When i bought the double strength and started using it, i had a reaction and almost lost consciousness.Tell me, does the manufacturer of corega produces tablets without mint and without fragrance? like a cream, the cream comes with a neutral taste.Why are there no tablet? telephone i wanted to clarify one more point.If there are no fragrance-free tablets in the corega line, maybe doctors can recommend some other brand? someone has to make it.People are sick and need to be treated with something.Maybe they will advise something.They don't know anything.Then, please, clarify, if they don't make it, then at least which type contains the minimum, the bare minimum.I would like to find out this information.Will you call from this number that i am calling? so that i write it down".

• Brand Name: COREGA DENTURE CLEANSING TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road, suite 200; warren, NJ 07059
• MDR Report Key: 18442024
• MDR Text Key: 331865280
• Report Number: 1020379-2023-00041
• Device Sequence Number: 1
• Product Code: EFT
• 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: 12/18/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/04/2024
• 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
• Patient Outcome(s): Other
• Patient Sex: Female