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

Device Problem Insufficient Information (3190)

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

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Hospitalisation [hospitalisation], device use error [device use error].Case description: this case was reported by a dentist via call center representative and described the occurrence of hospitalisation in a male patient who received double salt dental adhesive cream (new poligrip sa) cream for an unknown indication.Concurrent medical conditions included denture wearer and living in care.On an unknown date, the patient started new poligrip sa.On (b)(6) 2021, an unknown time after starting new poligrip sa, the patient experienced hospitalisation (serious criteria hospitalization).On an unknown date, the patient experienced device use error.On an unknown date, the outcome of the hospitalisation and device use error were unknown.It was unknown if the reporter considered the hospitalisation and device use error 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 patient (reporter's father) with long-term care level 5 was wearing full dentures and using poligrip with green package (probably new poligrip sa).The patient had used a relatively much amount and the cream became sloppy while eating food because the patient did not follow the usage of new poligrip sa.On (b)(6) 2021, the patient was admitted to a hospital.A physician told to stop using new poligrip sa during hospitalization because it might cause aspiration pneumonia.Follow-up information received from the reporting dentist via sales rep on 22 january 2021 [clinical course], patient: male in his 80s, as of (b)(6) 2021, the reporter was considering if new poligrip sa should be continued.Follow-up information received from the reporting dentist via sales rep on 25 january 2021 suspect product: double salt dental adhesive cream (new poligrip sa) cream for denture wearer on (b)(6) 2021, a physician told to stop using new poligrip sa during hospitalization because it might cause aspiration pneumonia.The reporter (dentist) had not heard of such an event.On (b)(6) 2021, a hospital staff stopped using new poligrip sa.The reporter wanted to continue using new poligrip sa in terms of mastication and articulation.On (b)(6) 2021, the reporter called twice.The hospital told that using new poligrip sa to the patient (reporter's father) would be accepted if a nurse could give an instruction when using it or the reporter could perform tissue conditioning.

• 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: 11257665
• MDR Text Key: 233088816
• Report Number: 3003721894-2021-00028
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 01/22/2021

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: 01/22/2021
• Initial Date FDA Received: 02/01/2021
• 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): Hospitalization
• Patient Age: 90 YR