MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA ULTRA CREAM WITHOUT FLAVOR; DENTURE ADHESIVE

Lot Number P14063

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Hospitalization (unknown cause) [hospitalization].Case description: this case was reported by a consumer via other (distributor) and described the occurrence of hospitalization (unknown cause) in a (b)(6)-year-old female patient who received triple salt dental adhesive cream (corega ultra cream without flavor) cream for denture wearer.On an unknown date, the patient started corega ultra cream without flavor.On an unknown date, an unknown time after starting corega ultra cream without flavor, the patient experienced hospitalization (unknown cause) (serious criteria hospitalization and gsk medically significant).On an unknown date, the outcome of the hospitalization (unknown cause) was unknown.It was unknown if the reporter considered the hospitalization (unknown cause) to be related to corega ultra cream without flavor.The patient's niece reported (via distributor) that her aunt was hospitalized (unknown cause).No further information was provided.Argus case number (b)(4) is a duplicate of (b)(4).All future correspondence will be submitted to (b)(4).

• Brand Name: COREGA ULTRA CREAM WITHOUT FLAVOR
• 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 27709 ; 8888255249
• MDR Report Key: 4877412
• MDR Text Key: 6060682
• Report Number: 9681138-2015-00034
• 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: Foreign,Consumer
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: P14063
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 48 YR