MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Kidney stones [renal stone].Case description: this case was reported by a consumer via interactive digital media and described the occurrence of renal stone in a patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced renal stone (serious criteria gsk medically significant).The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the renal stone was unknown.It was unknown if the reporter considered the renal stone to be related to corega (unspecified denture adhesive or denture cleanser) 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 stated that the amount of sodium in the product is huge.This crystalizes and becomes kidney stones.

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 9329661
• MDR Text Key: 166935177
• Report Number: 3003721894-2019-00331
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 11/04/2019

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: 11/04/2019
• Initial Date FDA Received: 11/15/2019
• 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