MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD DUNGARVAN, WATERFORD NEW POLIGRIP SI; DENTURE ADHESIVE

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

Patient Problem Cough (4457)

Event Type  Injury  

Event Description

Cough [cough], aspiration [aspiration], chest discomfort [chest abnormal feeling of], dyspnoea [dyspnoea].Case description: this case was reported by a consumer via call center representative and described the occurrence of cough in a (b)(6) male patient who received double salt dental adhesive cream (new poligrip si) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip si.On an unknown date, an unknown time after starting new poligrip si, the patient experienced cough, aspiration (serious criteria gsk medically significant), chest abnormal feeling of and dyspnoea.On an unknown date, the outcome of the cough, aspiration, chest abnormal feeling of and dyspnoea were unknown.The reporter considered the cough to be related to new poligrip si.It was unknown if the reporter considered the aspiration, chest abnormal feeling of and dyspnoea to be related to new poligrip si.[clinical course]: on an unknown date, the patient had been using new poligrip for 3-5 years.The patient had been using new poligrip si currently.The lower teeth was implant but the upper teeth were not the implant, so the patient had been using the complete denture.The magnet for denture came off, so the patient applied new poligrip si to hold for wearing.The patient tended to apply a lot of amount on, so when the patient took off the denture, the stabilizer left in the mouth and it was hard to remove it.The patient rinsed with hot water or used the cloth to wipe, but the stabilizer was not removed completely and stayed around the throat.That came into the trachea and that leaded to cough.The patient visited the physician, but the patient was suggested to visit the dentist, but the patient was diagnosed that new poligrip si was a cause of cough.The patient experienced cough and aspiration (serious criteria gsk medically significant), chest abnormal feeling and dyspnoea.The patient was not able to have a meal without applying the stabilizer and had to use new poligrip si, so the patient did not know what to do with reporter's comment.The patient visited the physician, but the patient was suggested to visit the dentist, but the patient was diagnosed that new poligrip si was a cause of cough.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: NEW POLIGRIP SI
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD DUNGARVAN, WATERFORD; dungarvan, waterford ; EI
• MDR Report Key: 12480767
• MDR Text Key: 282297683
• Report Number: 3003721894-2021-00323
• 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: 09/08/2021

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: 09/08/2021
• Initial Date FDA Received: 09/16/2021
• 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
• Patient Age: 72 YR