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

Lot Number V4084

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Type  Injury  

Event Description

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.

• Brand Name: COREGA SUPER CREMA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD.; dungarvan ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC
• MDR Report Key: 4877837
• MDR Text Key: 6060693
• Report Number: 9681138-2015-00025
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/27/2017
• Device Lot Number: V4084
• 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: CLONAZEPAM, UNK
• Patient Outcome(s): Death; Other
• Patient Age: 96 YR
• Patient Weight: 56