MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SA2; DENTURE ADHESIVE

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Aspiration [aspiration].Cough [cough].Case description: this case was reported by a consumer via call center representative and described the occurrence of aspiration in a (b)(6) male patient who received double salt dental adhesive cream (new poligrip sa2) cream for denture wearer.Concurrent medical conditions included denture wearer.Concomitant products included double salt dental adhesive cream (poligrip).On an unknown date, the patient started new poligrip sa2.On an unknown date, an unknown time after starting new poligrip sa2 and poligrip, the patient experienced aspiration (serious criteria gsk medically significant).On an unknown date, the outcome of the aspiration was unknown.It was unknown if the reporter considered the aspiration to be related to new poligrip sa2.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] in 2017, the patient started using poligrip at a dentist's suggestion.On an unknown date, the patient used to use poligrip with a wide nozzle in the past, but at present, he was using poligrip with a thin nozzle.At first he had no problems.For the last 1-2 years, however, poligrip occasionally went into the trachea, making him cough (serious criteria gsk medically significant).He considered that was because poligrip started melting in the back of his mouth.No further information is expected.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: NEW POLIGRIP SA2
• 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: 12827820
• MDR Text Key: 280877371
• Report Number: 3003721894-2021-00380
• 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: 11/08/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/17/2021
• 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
• Treatment: 1) POLIGRIP (DOUBLE SALT DENTAL ADHESIVE CREAM)
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male