MAUDE Adverse Event Report: ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH POLIGRIP CUSHION COMFORT; DENTURE ADHESIVE

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

The cream ends up coming from underneath the dentures to all over my month inside, and ends up going do down my throat if i dont spit it out.Then i end up choke on the adhesive cream.I cant not eat anything i mean anything with the adhesive cream./gers all over my mouth; [oral discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a female patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number unk, expiry date unknown) for denture wearer.Concurrent medical conditions included hunger (end up really hungry) and crying (crying in bed,).Concomitant products included no therapy.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced choking (serious criteria gsk medically significant and other: gsk medically significant) and oral discomfort.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the choking, and oral discomfort were unknown.The reporter considered the choking and oral discomfort to be related to poligrip cushion comfort.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 adverse event information was received via email on 12 november 2020.Consumer stated: your poligrip denture cream the cushion & comfort one, i bought it the other day and i have used it a couple of times now and the 3 times i have used it for the 3 days i have had it has been a really bad experience.When i say bad experience i mean that.I cant not eat anything i mean anything with the adhesive cream.My teeth automatically comes out well they come out when i have only had them in for a hour if that.The cream ends up coming from underneath the dentures to all over my month inside and ends up going do down my throat if i dont spit it out then i end up choke on the adhesive cream.Oh and when i take my teeth out and try to clean out my mouth that is even horrible experience it literally ends up taking me a couple hours to get it all out of my mouth.So i can not eat it gers all over my mouth and end of the day i end up really hungry and crying in bed, the past 3 days now.So i decided for the first time in my life emailing about the product i will never buy this one again nor tell people to either.Thank you.

Event Description

The cream ends up coming from underneath the dentures to all over my month inside and ends up going down my throat if i dont spit it out then i end up choking on the adhesive cream.[choking] [accidental device ingestion] case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a female patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number unk, expiry date unknown) for denture wearer.Concurrent medical conditions included hunger (end up really hungry) and crying (crying in bed,).Concomitant products included no therapy.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced choking (serious criteria gsk medically significant and other: gsk medically significant) and oral discomfort.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the choking and oral discomfort were unknown.The reporter considered the choking and oral discomfort to be related to poligrip cushion comfort.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 adverse event information was received via email on 12 november 2020.Consumer stated, "your poligrip denture cream the cushion & comfort one, i bought it the other day and i have used it a couple of times now and the 3 times i have used it for the 3 days i have had it has been a really bad experience.When i say bad experience i mean that.I cant not eat anything i mean anything with the adhesive cream.My teeth automatically comes out well they come out when i have only had them in for a hour if that.The cream ends up coming from underneath the dentures to all over my month inside and ends up going down my throat if i dont spit it out then i end up choke on the adhesive cream.Oh and when i take my teeth out and try to clean out my mouth that is even horrible experience it literally ends up taking me a couple hours to get it all out of my mouth.So i can not eat it gets all over my mouth and end of the day i end up really hungry and crying in bed, the past 3 days now.So i decided for the first time in my life emailing about the product i will never buy this one again nor tell people to either.Thank you".This report is being resubmitted to capture corrections for the initial information received on 12 november 2020 and is as follows: additional event of "accidental device ingestion" was added in the case which inadvertently missed to capture during initial case processing.Event of "oral discomfort" was removed and concurrent medical conditions of hunger (end up really hungry) and crying (crying in bed,) were removed.No more corrections were done.

Manufacturer Narrative

Argus case : (b)(4).

• Brand Name: POLIGRIP CUSHION COMFORT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH; oberkirch baden-wurttemberg; GM
• MDR Report Key: 10913670
• MDR Text Key: 219132318
• Report Number: 3003341442-2020-00027
• 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
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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: 11/12/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other