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 Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Gives cancer [cancer].Case description: this case was reported by a consumer via call center representative and described the occurrence of cancer in a patient who received corega (corega (unspecified denture adhesive or denture cleanser)) cutaneous liquid 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 cancer (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 cancer was unknown.It was unknown if the reporter considered the cancer to be related to corega (unspecified denture adhesive or denture cleanser).Additional details, the patient stated the following about corega, gives cancer (as reported).

• 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; 8888255249
• MDR Report Key: 9500342
• MDR Text Key: 188993569
• Report Number: 3003721894-2019-00356
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• 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