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 Encephalopathy (1833)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Asphyxia [asphyxia].Hypoxic-ischaemic encephalopathy [hypoxic encephalopathy].Accidental device ingestion [accidental device ingestion].Case description: this case was reported by a non-health professional via call center representative and described the occurrence of asphyxia in a (b)(6) old male patient who received double salt dental adhesive cream (new poligrip sa) cream for an unknown indication.Concurrent medical conditions included hospitalisation and living in residential institution.On (b)(6) 2019, the patient started new poligrip sa.On (b)(6) 2019, an unknown time after starting new poligrip sa, the patient experienced asphyxia (serious criteria disability and gsk medically significant) and accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced hypoxic encephalopathy (serious criteria gsk medically significant).On an unknown date, the outcome of the asphyxia was resolved with sequelae and the outcome of the hypoxic encephalopathy and accidental device ingestion were unknown.It was unknown if the reporter considered the asphyxia, hypoxic encephalopathy and accidental device ingestion 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 (b)(6) 2019, the inpatient swallowed new poligrip sa and choked on it (seriousness: gsk medically significant).He was emergently taken to another hospital from the reporter's psychiatric hospital.It seemed he had swallowed a large amount of another patient's new poligrip sa.It was developing into a lawsuit.On an unknown date, the patient had recovered from the asphyxia.The reporter knew nothing other than that.Follow-up information received from the reporting non-health professional on (b)(6) 2020.[clinical course] on an unknown date, the patient lived in an aged-care facility of hospital a.On (b)(6) 2019, the inpatient swallowed new poligrip sa and choked on it (seriousness: persistent or significant disability/incapacity and gsk medically significant).As of (b)(6) 2020, the patient had recovered from the asphyxia with sequelae of hypoxic-ischaemic encephalopathy.The outcome of the hypoxic-ischaemic encephalopathy was unknown.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
• Manufacturer Contact: po box 13398; research triangle park, nc ; 8255249
• MDR Report Key: 10020294
• MDR Text Key: 196919787
• Report Number: 3003721894-2020-00099
• 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: 04/06/2020

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: 04/06/2020
• Initial Date FDA Received: 05/04/2020
• 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; Disability
• Patient Age: 90 YR