MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SA; DENTURE ADHESIVE

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Cardiac failure [cardiac failure].Case description: this case was reported by a consumer via licensee and described the occurrence of cardiac failure in a elderly patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer and heart disorder.On an unknown date, the patient started new poligrip sa.On an unknown date, an unknown time after starting new poligrip sa, the patient experienced cardiac failure (serious criteria gsk medically significant).On an unknown date, the outcome of the cardiac failure was unknown.The reporter considered the cardiac failure to be probably related to new poligrip sa.[clinical course] concurrent medical condition: bad heart.On an unknown date, the reporter's elderly parent was using new poligrip sa.New poligrip sa would dissolve when using it, and the patient would swallow it with no surprise.The patient had a bad heart.The patient experienced cardiac failure (serious criteria gsk medically significant) and the cause was unknown.The patient was re-examining the dietary habits, but the physician suspected that the patient was taking salt contents according to the values of the blood test.As a presumable cause, it could be sodium included the dentures adhesive that the patient was using.No further information is expected.

• Brand Name: NEW POLIGRIP SA
• 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: 13051859
• MDR Text Key: 286452052
• Report Number: 3003721894-2021-00398
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/21/2021
• 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