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 Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Urinary retention [urinary retention].Weight increased [weight increased].Case description: this case was reported by a consumer via call center representative and described the occurrence of urinary retention in a elderly female patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer and cardiac failure.In 2021, the patient started new poligrip sa.On an unknown date, an unknown time after starting new poligrip sa, the patient experienced urinary retention (serious criteria gsk medically significant) and weight increased.On an unknown date, the outcome of the urinary retention and weight increased were recovered/resolved.It was unknown if the reporter considered the urinary retention and weight increased to be related to new poligrip sa.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, the reporter's mother was born during the first decade of showa period and had cardiac failure as of the reporting date.Since she lost weight and her complete denture was no longer snug, she bought new poligrip sa 75 g and used only once 2-3 weeks ago.After using, she experienced complete urinary retention (serious criteria gsk medically significant).Since urine was not excreted, her weight increased (serious criteria non-serious).On an unknown date, she consulted with a physician and was prescribed diuretic drugs.Although it was not improved by taking 3 types of diuretic drugs, the symptom was relieved by adding 4th diuretic drug, and she could pass urine as of the reporting date.(the names of diuretic drugs were unknown) the outcome of the urinary retention and weight increased were recovered/resolved.On an unknown date, the reporter read the package insert of new poligrip sa and found that salt was included in ingredients.The reporter's mother was under restrictions of salt intake of 6 g a day and water intake.The physician told that it was more harmful not to take a meal and the patient should use this product while taking diuretic drugs.No further information is expected.

• Brand Name: NEW POLIGRIP SA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 12532422
• MDR Text Key: 273339828
• Report Number: 3003721894-2021-00328
• 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: 09/15/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/27/2021
• 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