MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA DENTURE ADHESIVE CREAM

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Patient died [unknown cause of death].Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a female patient who received double salt dental adhesive cream (corega denture adhesive cream) cream for denture wearer.On an unknown date, the patient started corega denture adhesive cream.On an unknown date, an unknown time after starting corega denture adhesive cream, the patient experienced death nos (serious criteria death and gsk medically significant).The action taken with corega denture adhesive cream was unknown.On an unknown date, the outcome of the death nos was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos to be related to corega denture adhesive 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 reported that their mother had died and she had dental prosthesis.As it moved she removed them and applied it.This case was linked with case (b)(4) (same reporter).

• Brand Name: COREGA DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 10407781
• MDR Text Key: 202934470
• Report Number: 3003721894-2020-00221
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

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
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/14/2020
• 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
• Treatment: NO THERAPY
• Patient Outcome(s): Death; Other