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

Lot Number CF4T

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Haemorrhage [haemorrhage].Case description: this case was reported by a non-health professional via call center representative and described the occurrence of haemorrhage in a male patient who received double salt dental adhesive cream (new poligrip sa) cream (batch number cf4t, expiry date unknown) for denture wearer.Concurrent medical conditions included denture wearer.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 haemorrhage (serious criteria gsk medically significant).On an unknown date, the outcome of the haemorrhage was recovered/resolved.It was unknown if the reporter considered the haemorrhage 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, haemorrhage did not stop (serious criteria gsk medically significant).On an unknown date, a customer used new poligrip sa 75 g, and haemorrhage did not stop.So, the reporter dealt with it by refund in the store.The symptom seemed to be subsided as the patient consulted a hospital, and the bleeding had stopped when he came to the store.Patient information was unknown other than gender.No further information will be provided due to the refusal of the reporting non-health professional.

• Brand Name: NEW POLIGRIP SA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 12307111
• MDR Text Key: 266004870
• Report Number: 3003721894-2021-00268
• 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
• Type of Report: Initial
• Report Date: 07/20/2021

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
• Device Lot Number: CF4T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/11/2021
• 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