MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD ULTRA COREGA CREAM; DENTURE ADHESIVE

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

Patient Problem Ischemia (1942)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Aneurysm [aneurysm].Mesenteric ischemia [mesenteric ischemia].Case description: this case was reported by a dentist via sales rep and described the occurrence of aneurysm in a (b)(6) year-old female patient who received polyethylene oxide, sodium carboxymethylcellulose (corega adhesive strips) strip for drug use for unknown indication.On an unknown date, the patient started corega adhesive strips.On an unknown date, an unknown time after starting corega adhesive strips, the patient experienced aneurysm and mesenteric ischemia (serious criteria gsk medically significant).On an unknown date, the outcome of the aneurysm and mesenteric ischemia were unknown.It was unknown if the reporter considered the aneurysm and mesenteric ischemia to be related to corega adhesive strips.Additional details: the patients suffered aneurysm and mesenteric ischemia and they believe that these are related to the use of adhesive corega.Action taken with corega was withdrawn with dechallenge unknown.This case was linked to (b)(4).This report is being resubmitted to capture corrections.The information was received on 06 jun 2019 and is as follows: the suspect product name was changed to ultra corega cream.

• Brand Name: ULTRA COREGA CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 8764706
• MDR Text Key: 150153142
• Report Number: 3003721894-2019-00181
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 06/06/2019

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: 06/06/2019
• Initial Date FDA Received: 07/05/2019
• 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
• Patient Age: 80 YR