MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA PRO GUARD RETAINER; DENTURE CLEANSER

Lot Number 949T

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 04/12/2023

Event Type  Injury  

Event Description

The medical report, whose diagnosis was "poisoning [accidental poisoning] accidentally swallowed a corega splint and prosthesis cleaning [accidental device ingestion].I started to feel very anxious [anxiety].A feeling of coolness [feeling cool].Discomfort in my stomach [stomach discomfort].Fatigue i was feeling [fatigue].Diarrhea [diarrhea].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental ingestion of product in a female patient who received denture cleanser (corega pro guard retainer) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included feeling unwell.On an unknown date, the patient started corega pro guard retainer.On an unknown date, an unknown time after starting corega pro guard retainer, the patient experienced accidental ingestion of product, wrong product administered and product confusion.The action taken with corega pro guard retainer was unknown.On an unknown date, the outcome of the accidental ingestion of product, wrong product administered and product confusion were unknown.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 (email) on 20apr2023.The consumer reported, "i accidentally swallowed a corega cleaning tablet for splints and prostheses, thinking it was an effervescent tablet of eferalgan (paracetamol) because i was feeling unwell.I would like to know if it is dangerous and if i should go to the emergency room".Spanish narrative: he ingerido accidentalmente una pastilla limpiadora de férulas y prótesis de corega, confundiéndola con una efervescente de eferalgán (paracetamol) pues me encontraba mal.Quisiera saber si es peligroso y si debo ir a urgencias.Follow-up information received on (b)(6) 2023 by a consumer via call center representative (email).Consumer stated that while on holiday on 12apr2023 at 6 am i mistakenly swallowed (as i did not turn on the light so as not to wake my roommate) a corega effervescent tablet -which i use to clean a dental splint - dissolved in water, confusing it with a tablet, also effervescent, of eferalgan (paracetamol 500 g.), as i had a cold and got worse when i arrived - due to the change of weather - and i felt very ill, without being able to sleep all night.I realised when i swallowed the solution that i had mistaken the pill, because it tasted like "mint" and the eferalgan tastes like bitter sparkling water.I started to feel very anxious, a feeling of coolness and discomfort in my stomach.I tried to vomit but i didn't succeed.I panicked, woke up my partner and we called insurance in advance.A company with which i had, fortunately, taken out travel i decided not to eat breakfast in case i had to have a gastric lavage.From the (whose performance was unbeatable in my case), the informed me to go to the nearest hospital hotel - where we were staying - which was the hospital.The insurance company took care of the costs involved.There i went to the emergency service, where i explained my case and, as i was apparently feeling quite well - despite the fatigue and discomfort i was feeling- i was treated after a three-hour wait.The treatment from doctors, nurses, service staff, etc., was great: understanding, very professional and caring.The doctor who saw me asked me about all my symptoms, having informed me of all the chemical components of the corega tablets and their possible adverse health effects, if ingested.I showed him all the medication i was taking, as i am being treated for breast cancer, anxiety and depression, as well as, at the time, sinusitis and pharyngitis.He told me that, although there was probably nothing wrong with me because i had taken a tablet, he would prefer to do a blood test.So it was after another two hours of waiting.And after another two hours, the doctor very kindly informed me that everything was ok in my blood test: renal function ok, liver function ok.All the parameters were fine.The only thing was that there was an altered level in one of the metals or minerals (a component of corega that i don't remember what it was), which should appear as "0" (zero) and in my case, it showed "1" (one).He reassured me that it was a very low level and therefore not toxic enough; to be calm, to eat and take all my medication.He warned me that if i noticed any strange symptoms or if it got worse, to go back there, to the emergency room.After that i started to feel more or less fine, with an unwell stomach, diarrhoea and a bit of anguish, but nothing more.The next day i was fine (except for my cold symptoms).Below is a picture of the medication i am taking, as well as the two pills and their packaging (so you can see how they look alike) and also the medical report, whose diagnosis was "poisoning".Fortunately nothing serious has happened to me and i recognise that it was my mistake! but i think you may want to keep this in mind, as there are many older people who use the denture cleaning tablets, as well as adults who wear mouth guards, and children who clean their braces.I suggest changing the packaging and wrapping of corega tabs so that no one else mistakes them for a medicine.Current treatment was reported as lorazepam 1mg tablet, nasonex 50 mcg nasal spray 4 spray a day for 7 days, prednisone 30mg tablet a day for 5 days next half a tablet a day for 5 days, tamoxifen 20 mg tablet a day for 30 days, heipram 10mg film coated tablet, valium 5mg tablet for anxiety and insomnia if administer at going to bed.Omeprazole 20 mg capsule without chewing in morning with juice or water warn if taking warfarin 1 capsule every 12 hour chronic.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: COREGA PRO GUARD RETAINER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren 07059 ; 8888255249
• MDR Report Key: 16961347
• MDR Text Key: 315748347
• Report Number: 1020379-2023-00020
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/12/2023

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: 949T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/19/2023
• 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: 1) EFERALGAN (PARACETAMOL) EFFERVESCENT TABLET.; 2) LORAZEPAM (LORAZEPAM).; 3) NASONEX (MOMETASONE FUROATE) NASAL SPRAY.; 4) PREDNISONE (PREDNISONE) TABLET.; 5) PREDNISONE (PREDNISONE) TABLET.; 6) TAMOXIFEN (TAMOXIFEN) TABLET.; 7) HEIPRAM (ESCITALOPRAM OXALATE) FILM-COATED TABL.; 8) VALIUM (DIAZEPAM) TABLET.; 9) OMEPRAZOLE (OMEPRAZOLE) CAPSULE.
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female