MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP DENTURE ADHESIVE CREAM

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  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

My 2 year old grandson took some poligrip.[accidental device ingestion by a child].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a 2-year-old male patient who received double salt dental adhesive cream (poligrip denture adhesive cream) cream (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started poligrip denture adhesive cream.On an unknown date, an unknown time after starting poligrip denture adhesive cream, the patient experienced accidental device ingestion by a child (serious criteria haleon medically significant).The action taken with poligrip denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion by a child was unknown.It was unknown if the reporter considered the accidental device ingestion by a child to be related to poligrip denture adhesive cream.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received from a consumer via (phone) call center representative on (b)(6) 2024.It was reported that, "my 2 year old grandson took some poligrip.".

• Brand Name: POLIGRIP DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 18872526
• MDR Text Key: 337292754
• Report Number: 3003721894-2024-00031
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/11/2024
• 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: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 24 MO
• Patient Sex: Male