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

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

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), corega denture fixative cream.Corega denture fixative cream is marketed as super poligrip in the us.

Event Description

Worsening of celiac disease [celiac disease], [condition aggravated].Organic difficulty (sic) [ill-defined disorder].Case description: this case was reported by a consumer via call center representative and described the occurrence of celiac disease in a male patient who received double salt dental adhesive cream (corega denture fixative cream) cream for drug use for unknown indication.Concurrent medical conditions included celiac disease.On an unknown date, the patient started corega denture fixative cream.On an unknown date, an unknown time after starting corega denture fixative cream, the patient experienced celiac disease (serious criteria gsk medically significant), condition aggravated and ill-defined disorder.The action taken with corega denture fixative cream was unknown.On an unknown date, the outcome of the celiac disease, condition aggravated and ill-defined disorder were unknown.It was unknown if the reporter considered the celiac disease, condition aggravated and ill-defined disorder to be related to corega denture fixative cream.Additional details: the consumer has been using corega denture fixative cream since 30 days ago (did not specify).Since he started using it, he presents with worsening of the celiac disease referred as organic difficulty (sic; did not specify).

• Brand Name: COREGA DENTURE FIXATIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8331439
• MDR Text Key: 135913734
• Report Number: 3003721894-2019-00046
• 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: 02/04/2019

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: 02/04/2019
• Initial Date FDA Received: 02/12/2019
• 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