COREGA SUPER CREMA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-23 for COREGA SUPER CREMA manufactured by Glaxosmithkline Dungarvan Ltd..

Event Text Entries

[6060693] Accidental exposure to product [accidental exposure to product], misuse [device misuse], death due to unknown cause [death nos]. Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental exposure to product in a (b)(6) female patient who received triple salt dental adhesive cream (corega super crema) cream (batch number v4084, expiry date unk) for denture adhesion. Concurrent medical conditions included parkinson's disease and denture wearer, concomitant products included clonazepam. On an unknown date, the patient started corega super crema. On an unknown date, an unknown time after starting corega super crema, the patient experienced accidental exposure to product. On an unknown date, the outcome of the accidental exposure to product was unknown. It was unknown if the reporter considered the accidental exposure to product to be related to super corega crema. This report is made by gsk without prejudice and does not implant any admission or liability for the incident or its consequences. Additional details: this report refers to (b)(6) female consumer who has been using corega super crema for many years. She always used corega one time per day but lately she started applying it two times a day (although this is not recommended in product label). Consumer's daughter informed that the patient swallowed the product and residues remained in her throat. She consulted with a physician who informed that her digestive system is deteriorated because of old age. Also, she is a bedridden patient and has parkinson's disease. No more information was available. Follow-up was received on (b)(6) 2014. The patient's husband reported that his wife passed away. Date of death and cause of death were not reported. Case revision of original data: the patient received the double salt formulation of corega super. Creama and not the triple salt formulation of corega super crema as the triple salt formulation has been discontinued.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2015-00025
• MDR Report Key: 4877837
• Report Source: 04
• Date Received: 2015-06-23
• Date of Report: 2014-12-04
• Date Added to Maude: 2015-07-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: PO BOX 13398
• Manufacturer City: RESEARCH TRIANGLE PARK NC
• Manufacturer Country: US
• Manufacturer G1: GSK
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COREGA SUPER CREMA
• Generic Name: DENTURE ADHESIVE
• Product Code: KOL
• Date Received: 2015-06-23
• Lot Number: V4084
• Device Expiration Date: 2017-02-27
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GLAXOSMITHKLINE DUNGARVAN LTD.
• Manufacturer Address: DUNGARVAN EI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Other	2015-06-23