MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); DENTURE ADHESIVE

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I had a stomach blockage after that, obstruction gastric.I had to scrape it and it fell off in my mouth, wrong technique in device usage process.Case description: this case was reported by a consumer via call center representative and described the occurrence of obstruction gastric in a female patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number unk, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip original (zinc free formula).On an unknown date, an unknown time after starting super poligrip original (zinc free formula), the patient experienced obstruction gastric (serious criteria gsk medically significant and other: gsk medically significant) and wrong technique in device usage process.The action taken with super poligrip original (zinc free formula) was unknown.On an unknown date, the outcome of the obstruction gastric and wrong technique in device usage process were recovering/resolving.It was unknown if the reporter considered the obstruction gastric and wrong technique in device usage process to be related to super poligrip original (zinc free formula).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 from consumer via call center representative (phone) on (b)(6) 2022.Consumer reported that "i have used poligrip denture adhesive cream and my teeth did not pick this up, so it got stuck to my mouth i had to scrape it and it fell off in my mouth.Tell the people with your report that they should not put too much of it.I have had a month of misery.I had a stomach blockage after that.The doctor didn't think that caused it, so i had an mri.I threw the box already, but i still have the product.I can't see the numbers on the bottom i need a magnifying glass and i don't have one.I would prefer not to be contacted again".

• Brand Name: SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
• 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: 14490937
• MDR Text Key: 294574583
• Report Number: 3003721894-2022-00066
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2022

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: 05/13/2022
• Initial Date FDA Received: 05/24/2022
• 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