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

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

Patient Problem Stomach Ulceration (4488)

Event Type  Injury  

Event Description

I sometimes swallow some of it [accidental device ingestion].Upsetting my stomach [upset stomach].It still hurts [stomach pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 78-year-old patient who received double salt dental adhesive cream (poligrip ultra fresh denture adhesive cream) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included gastric ulcer.In 2022, the patient started poligrip ultra fresh denture adhesive cream.In 2022, an unknown time after starting poligrip ultra fresh denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant ), upset stomach and stomach pain.The action taken with poligrip ultra fresh denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the upset stomach and stomach pain were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion to be related to poligrip ultra fresh denture adhesive cream.The reporter considered the upset stomach and stomach pain to be related to poligrip ultra fresh denture adhesive cream.This report is made by gsk/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 consumer via call center representative (phone) on 14oct2022.The consumer stated that "okay.I bought some of your poligrip maybe 3-4 months ago and i used it until 2 days ago, when i received a notification from that it's been recalled and i have stomach ulcers and ever since i've been using it, it's been upsetting my stomach.I didn't know what it was, but i sometimes swallow some of it and i guess it upsets my stomach ulcers.I was using fixodent before that and didn't have that issue.I don't know, i threw it away.Yeah, i started using it like 3-4 months ago.No, i stopped using it this wednesday, when i read the notice from.I was wondering if you'd know what to do to make it better, because i'm not sure.Well, i have an appointment with my doctor next week, i guess i'll bring that up with them as well.No, it still hurts.Alright, have a nice day".

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: POLIGRIP ULTRA FRESH 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 ; 8888255249
• MDR Report Key: 15759958
• MDR Text Key: 303328240
• Report Number: 3003721894-2022-00163
• 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: 10/14/2022

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: 10/14/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Age: 78 YR