MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA ULTRA 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 Type  Injury  

Manufacturer Narrative

Argus case : (b)(4).

Event Description

The adhesive goes to the intestine and the stomach [accidental device ingestion].I had an infection in the urine / urinary infection / strong infection / there were 3 bacteria [urinary infection].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) male patient who received double salt dental adhesive cream (corega ultra cream) cream (batch number unk, expiry date unknown) for denture wearer.On an unknown date, the patient started corega ultra cream.On an unknown date, an unknown time after starting corega ultra cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant) and urinary infection.The action taken with corega ultra cream was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the urinary infection was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion and urinary infection to be related to corega ultra cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: consumer used corega in an upper partial denture.A few months ago he had an infection in the urine, which was now over.And he thought if it be the corega adhesive he used.The way to ingest it, obviously because the adhesive disintegrates.It disintegrates during the day and he was asking where does it go.Obviously it went to the intestine, to the stomach.His question was, if it cause an urinary infection.Because he had a strong infection.He started to investigate and there were doctors, dentists, even people who post on facebook: be careful with the use of corega and he said: how.This was supposed to be a first class product quality.That was why he kept thinking.When he started using corega, he started with an urinary infection.He did do not want to say that it was that but that they investigate if it was a cause of it.He started using it and about 3 months after he started using it.He did not want to say that it was corega but he thought it had something to do with it.He went to his family doctor but sincehei was going through the pandemic, he did not want to attend to him so that they could do blood and urine tests.He chose to do it with an urologist and in a clinical analysis center, where he was acknowledge that he had 3 bacteria.Because the urologist was very fortuitous, he was very superficial.He was thinking about the prostate and other things but he never told him that he was using corega because he did not see the need.The urologist prescribed him a very expensive and effective medicine that in a week the bacteria disappeared.Because the following week he had a urine test, a urine culture test and it came out negative.

• Brand Name: COREGA ULTRA CREAM
• 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: 11048049
• MDR Text Key: 228626153
• Report Number: 3003721894-2020-00358
• 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: 12/07/2020

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/21/2020
• 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 Age: 58 YR