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

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

Patient Problem Cough (4457)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

When i finally got through this i coughed up a very tiny pink piece [foreign body in throat] i started coughing for about half hour.[cough].Case description: this case was reported by a consumer via call center representative and described the occurrence of cough in a male patient who received double salt dental adhesive cream (poligrip original) cream (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started poligrip original.On an unknown date, an unknown time after starting poligrip original, the patient experienced cough.The action taken with poligrip original was unknown.On an unknown date, the outcome of the cough was unknown.The reporter considered the cough 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 information: the case was received via call center representative (email) on 1 jun 2021.The consumer reported that "i had used your products for many years.But last time i used it a little (about the same size as an ant) and i started coughing for about half hour.I thought i might die.Your company may become sued over this kind of event and cost billions of dollars.I just wanted you to be warned.Get in touch with me after testing if there is a problem.".The case is linked to (b)(4) and (b)(4).Error correction was received on 1 jun 2021.Product should have been tagged as poligrip denture adhesive cream unknown variant and size.Follow up 2 was received on 1 june 2021 additional details: "when i finally got through this i coughed up a very tiny pink piece, and it scared me very much." event "foreign body in throat" was added and it is a serious event hence the case upgraded as serious.Follow up 3 was received on 23 june 2021.Additional details: "i hate to beat this to death, but i think many people have died or got sick already, but never associated it with your product.I happened to spit up a very small piece of pink material that i recognized as the same color as the product.If i were you, i'd take every product of this sort to save people from having swallowed and had nothing to compare it with your product.You should remove it from every shelf in the world to be on the safe side.You might even have to go into bankruptcy and lose everything.You have a great product and i have used it for years and i know you don't want to lose everything, but you maybe will.".

• 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: 12102416
• MDR Text Key: 268510952
• Report Number: 3003721894-2021-00239
• 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: 06/01/2021

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: 06/01/2021
• Initial Date FDA Received: 07/01/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 81 YR