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

Lot Number 5K4E1

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Event Description

Many times i'm eating and it starts to come out, there's no harm in ingesting it, right? [accidental device ingestion].Now it has given me a change i had an intestinal crisis [gastrointestinal disorder].Now it has given me a change constipation [constipation].Unpleasant stickiness starts to come out in my mouth [oral discomfort].My stools came out hard [stools hard].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received double salt dental adhesive cream (corega sin sabor) cream (batch number 5k4e1, expiry date 30th april 2024) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started corega sin sabor.On an unknown date, an unknown time after starting corega sin sabor, the patient experienced accidental device ingestion (serious criteria hospitalization and haleon medically significant), gastrointestinal disorder (serious criteria hospitalization), constipation (serious criteria hospitalization), oral discomfort (serious criteria hospitalization), stools hard (serious criteria hospitalization) and product complaint.On an unknown date, the outcome of the accidental device ingestion, gastrointestinal disorder, constipation, oral discomfort, stools hard and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion, oral discomfort and stools hard to be related to corega sin sabor.The reporter considered the gastrointestinal disorder and constipation to be related to corega sin sabor.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received from a consumer via call center representative (phone) on 06dec2023.The consumer reported that, "i bought another corega without any flavor.I didn't even buy it, it was mine.My dentist told me it was good.But you say it lasts for 12 hours, but the one i have doesn't even last 6 hours, after a while a really unpleasant stickiness starts to come out in my mouth, then it gets on my lipstick.Once a little liquid came out.I had never used it.I keep it in the bathroom.Many times i'm eating and it starts to come out, there's no harm in ingesting it, right? now it has given me a change.I had an intestinal crisis, constipation.Now that i'm remembering exactly how long i've been using the product, i went to the hospital.My stools came out hard.I don't remember what day it was, i ended up in the hospital twice.I don't even use it every day.It was unusually constipated, i've never had constipation, i even thought it was the diet, but i didn't change anything about my diet, i keep eating the same thing".Follow-up information was received on 06dec2023 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for lot number 5k4e1.Investigation evaluation: the product is manufactured according to established procedures and is subjected to physicochemical tests for batch release.It is common to see a small amount of phase separation in adhesive creams that use mineral oil as is the case with corega.This separation occurs mainly at the tip of the tube, where the liquid will be naturally stored, mainly due temperature variations.It is concluded that this type of complaints can be associated with an incorrect conservation of the product by the consumer, which means that, in some cases, the appearance of the product is more liquid.It is important to respect the storage conditions indicated in the art of the product: store at room temperature.Complaint conclusion : the complaint conclusion stands unsubstantiated.The pqc number was reported as (b)(4).Initial and follow up were processed together.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: COREGA SIN SABOR
• 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
• MDR Report Key: 18409459
• MDR Text Key: 331506758
• Report Number: 3003721894-2023-00215
• 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: 12/06/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Lot Number: 5K4E1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female