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

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

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Swallowed quite a bit of it [accidental device ingestion], she has been having pains in her stomach [stomach pain].She ended up putting too much on the denture [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received double salt dental adhesive cream (poligrip original) cream (batch number unk, expiry date unknown) for denture wearer.On an unknown date, the patient started poligrip original.On an unknown date, an unknown time after starting poligrip original, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), stomach pain and wrong technique in device usage process.The action taken with poligrip original was unknown.On an unknown date, the outcome of the accidental device ingestion, stomach pain and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion, stomach pain and wrong technique in device usage process to be related to poligrip original.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received via call centre representative (phone) on 18jan2022.Consumer reported that "poligrip i am calling for my mom, i just have a general question, she just recently got dentures she started using the poligrip, she ended up putting too much on the denture, and swallowed quite a bit of it.She has been having pains in her stomach ever since.I have to contact them? what are they going to do? no that's okay, but thank you for your help".

• Brand Name: POLIGRIP ORIGINAL
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 13382609
• MDR Text Key: 289249614
• Report Number: 3003721894-2022-00012
• 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: 01/18/2022

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: 01/18/2022
• Initial Date FDA Received: 01/28/2022
• 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: Female