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

Lot Number MA3W

Device Problem Product Quality Problem (1506)

Patient Problem Airway Obstruction (1699)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Throat had been obstructed [upper airway obstruction], could not swallow [unable to swallow], could not breathe [difficulty breathing], he was not applying hot water and cleaning it with a soft brush [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of upper airway obstruction in a male patient who received double salt dental adhesive cream (corega super) cream (batch number ma3w, expiry date 31st january 2023) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On an unknown date, the patient started corega super.On an unknown date, an unknown time after starting corega super, the patient experienced upper airway obstruction (serious criteria gsk medically significant and other: gsk medically significant), unable to swallow, difficulty breathing, wrong technique in device usage process and product complaint.On an unknown date, the outcome of the upper airway obstruction, unable to swallow, difficulty breathing, wrong technique in device usage process and product complaint were unknown.It was unknown if the reporter considered the upper airway obstruction, unable to swallow, difficulty breathing and wrong technique in device usage process to be related to corega super.Additional information: adverse event information was received via call center representative (phone) on 21 december 2020.The consumer called about corega super.He used it for 14 months, he always purchased this one from the pharmacy and it had very good adhesion performance.During the last month, he developed a problem, his throat had been obstructed and he could not swallow and sometimes breathe.He visited many doctors.He visited and even had a ct scan, but they could not find anything.He stopped use of this adhesive and two days later his pharynx automatically cleared.At night, when he stopped using it, the adhesion melted with the saliva.And he asked why this happened, it worked very well in the last 14 months, in the last month he presented this effect; he did not know whether the composition changed or if it was not melting with saliva or if he was doing something wrong himself.A month ago, on (b)(6), he started having this problem, and 5 to 6 days, about a week ago, he stopped having the problem when he stopped use of the product.He did not use the product as per the instructions.He had not applied hot water and did not clean it with a soft brush.Corega super was more adhesive lately and he removed the denture with more difficulty.He asked how he should use it.Consumer treated by a healthcare profession was none.Suspect drug was reported as corega super denture adhesive cream 40g.Follow up information was received on 5 january 2020 via quality assurance department regarding product complaint (b)(4) (batch number ma3w, expiry date 31st january 2023).This was the first complaint of this nature for this batch.A notification review check was carried out on this batch which related to manufacturing deviations, vendor investigations, change controls and laboratory investigations, there were no issues noted during the manufacture of this batch as per the defect of this complaint received.Therefore no further actions would be taken at this time.Complaint conclusion was unsubstantiated.

• Brand Name: COREGA SUPER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 11146486
• MDR Text Key: 231961374
• Report Number: 3003721894-2020-00387
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 12/21/2020

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: 01/31/2023
• Device Lot Number: MA3W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• 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
• Patient Outcome(s): Other