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

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

Patient Problems Urinary Tract Infection (2120); Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

3003721894-2019-00062 is associated with argus case (b)(4).Corega neutral taste is marketed in the us as poligrip denture cream.

Event Description

Urinary disorder [urinary tract disorder], absorption of small amount of product [accidental device ingestion], urinary infection [urinary infection].Case description: this case was reported by a pharmacist and described the occurrence of urinary tract disorder in a (b)(6) male patient who received double salt dental adhesive cream (corega cream mint flavor) cream for product used for unknown indication.On an unknown date, the patient started corega cream mint flavor.On an unknown date, an unknown time after starting corega cream mint flavor, the patient experienced urinary tract disorder and accidental device ingestion (serious criteria gsk medically significant).The action taken with corega cream mint flavor was unknown.On an unknown date, the outcome of the urinary tract disorder and accidental device ingestion were unknown.It was unknown if the reporter considered the urinary tract disorder and accidental device ingestion to be related to corega cream mint flavor.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the pharmacist patient was complaining because he noticed that he had urinary disorders with corega cream.Patient did not had this urinary disorder with other similar products.This experience was based on several periods of use.The patient apparently absorbed a little product.The patient concerned urinary disorder after each use it was related to several periods of use.Follow up information received on 15 mar 2019 from pharmacist: on an unknown date, the patient started corega neutral taste.On an unknown date, an unknown time after starting corega neutral taste, the patient experienced urinary infection.On an unknown date, the outcome of the urinary infection was unknown.It was unknown if the reporter considered the urinary infection to be related to corega neutral taste.Suspect drug was changed from corega cream mint flavor to corega neutral taste.Pharmacist could not provide patient details but confirmed that it concerns a male patient between 40 and 50 years old.Pharmacist mentioned that patient experienced urinary disorder and urinary infection each time that he used corega neutral taste (cream).This happened several times.Pharmacist also mentioned that patient had never been treated for these urinary problems.Pharmacist confirmed that patient was not treated with antibiotic of any other drugs for his urinary infection.So the symptoms disappeared spontaneously by stopping the use of corega.The patient used similar product to corega from another brand, he did not experienced any urinary disorder.

• Brand Name: COREGA NEUTRAL TASTE
• 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: 8448119
• MDR Text Key: 139707909
• Report Number: 3003721894-2019-00062
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 02/27/2019

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
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 03/25/2019
• 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: 55 YR