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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Toxicity (2333); Foreign Body In Patient (2687)

Event Type  Other  

Event Description

Suspected poisoning; complications (ill-defined disorder).Case description: this case was reported by a consumer via call center presentative and described the occurrence of poisoning in a female patient who received denture adhesive power-cmc or double salt (super corega powder) oral powder for product used for unknown indication.On an unknown date, the patient started super corega powder.On an unknown date, an unknown time after starting super corega powder, the patient experienced poisoning (serious criteria gsk medically significant) and ill-defined disorder.On an unknown date, the outcome of the poisoning and ill-defined disorder were not reported.It was unknown if the reporter considered the poisoning and ill-defined disorder to be related to super corega powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information included.This case was reported by a consumer via call center.On (b)(4) 2015 the consumer left a voice mail reporting that she used super corega powder and was presented some complications, she thought that could be a poisoning.Due to this, she decided to sent this voice mail, tried to clarify this issue.Action taken for device was unknown.

• Brand Name: SUPER COREGA POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD.; dungarvan ; EI
• Manufacturer (Section G): GLAXOSMITHKLINE DUNGARVAN LTD.
• Manufacturer Contact: po box 13398; research triangle park, NC 27709-0000 ; 8888255249
• MDR Report Key: 5025348
• MDR Text Key: 25144337
• Report Number: 3003721894-2015-00004
• 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,foreign
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 08/11/2015
• 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