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

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

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

Adhesive cream would keep going down the throat.Unintentionally eats the adhesive cream [accidental device ingestion].Developed abdominal pain [abdominal pain].He could not sleep [insomnia].His stomach hurt [stomach pain].Stickiness on his throat [throat discomfort].Keeps on spitting out phlegm [phlegm].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unk, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: haleon medically significant), abdominal pain, insomnia, stomach pain, throat discomfort and phlegm.The action taken with polident denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion, abdominal pain, insomnia, throat discomfort and phlegm were unknown and the outcome of the stomach pain was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion, abdominal pain, insomnia, stomach pain, throat discomfort and phlegm to be related to polident 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: adverse event information reported by a consumer via call center representative (phone) on 25nov2022.The consumer stated that, the male consumer has been using polident adhesive cream for few times.There was one time when he developed abdominal pain after using the product.When he woke up from the sleep, he could not sleep as he had abdominal pain.His stomach hurt.He is currently using the product but his stomach is not painful.When he uses the product, as the adhesive cream would keep going down the throat which would cause stickiness on his throat, and as it is strange, he keeps on spitting out phlegm.When he is using the product, he unintentionally eats the adhesive cream".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: POLIDENT 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: 16032352
• MDR Text Key: 305977341
• Report Number: 3003721894-2022-00204
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2022

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: 11/25/2022
• Initial Date FDA Received: 12/22/2022
• 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
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Sex: Male