MAUDE Adverse Event Report: POLIDENT DENTURE ADHESIVE MAX COMFORT

Lot Number	LV7C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Veeva case: (b)(4).
Event or Problem Description
Medication stuck in throat [medication stuck in throat] device used for unapproved schedule [device used for unapproved schedule].Case description: on 2024-07-16 a spontaneous case was reported in taiwan (province of china) by a consumer or other non-health professional via call center representative (phone).The report concerns a 95-year-old female consumer.On an unknown date in 2024, the consumer received polident denture adhesive max comfort (carbomer+carna cream), lot number lv7c and expiry date 2025-10, for indication denture fixative complication.No concomitant medications were reported.On an unknown date in 2024, after an unknown time of starting polident denture adhesive max comfort (carbomer+carna cream), the consumer experienced a medically significant event foreign body in throat (adhesive sticks to the throat/ felt like something was stuck in her throat).The outcome of the event foreign body in throat was not recovered/ not resolved/ ongoing.On an unknown date in 2024, the consumer experienced a non-serious event device use issue (she has been using adhesive three times a day).The outcome of the event device use issue was unknown.No medical history was reported.No drug history was reported.The action(s) taken were: for polident denture adhesive max comfort (carbomer+carna cream) was unknown.The dechallenge was unknown and rechallenge was not reported.The causality of event foreign body in throat with respect to suspect is related(reasonable possibility) and causality of event device use issue was reported/not assessable.This report is made by haleon without prejudice and doesn't imply any admission or liability for the incident or its consequences.The reporter provided the following comment: "my mother often uses polident denture adhesive cream, which i bought.Now she is using polident denture adhesive max comfort [with] good stability 70g.The adhesive sticks to the throat.I would like to ask how to remove this.Adhesive? or is this used improperly? she always reads the instructions, but she will apply it in key points and will not stick to the whole strip.For a while now she has been saying that her throat is sticky and she wants to spit out the sticky stuff.Now it is stuck in her throat.I don't know what suggestions you have.It has accumulated in large amounts at the front of her throat.Is there any way to help her flush this stuff out? logically speaking, the adhesive will not flow out after installation, right? when you take it off, you need to rinse it with warm water and scrub it, right? my mother has to re-stick it almost every once in a while, and the frequency of use is quite high.Does she have to brush it after she uses it? do you have to do this just to take off your dentures? she sticks to it almost every time she eats, and she takes it off after eating.Does she have to wash and rinse her mouth every time she takes it off? why does she have to be clingy for a while? are the dentures not fitting properly? is there any way to clean it up faster? is there anything effective that can effectively take it away, other than hot water.I have been using this adhesive for two months.She reported this problem to me a while ago.I asked her to use warm water.The oral adhesive can be cleaned, but there is still accumulation in the throat, so i wondered if there was something wrong with it.What is a quick way to flush away the adhesive accumulated in the throat? this problem has been happening for a while, but it will be obvious for a while, and it will be fine after washing it off, and then it will appear again after a while.She has been using adhesive three times a day, and the lower row of dentures will be re-adhered.The upper row is more stable, but it still needs to be re-adhesive occasionally.This may be because the dentures do not fit properly.I observed that she would spit out the sticky stuff in her throat.I originally thought it was phlegm, but after asking more about it, i found out that it was sticky stuff in her throat.And she didn't have a persistent cough, so it probably wasn't a lung problem.Today she was very sticky and didn't feel like vomiting.She just felt like something was stuck in her throat.My mother wanted to stabilize the dentures, so she used adhesive.The bottom part needed to be re-glued, and she would take the dentures out and wash them out because she said there would be things stuck inside.I haven't seen a doctor yet because my mother doesn't want to go.Lot: lv7cexp: 2025.10) does the consumer agree to provide pii: yes 2) does the consumer agree to follow-up? yes (the caller can be interviewed back) 3) the relationship between the patient and the caller's family.".

• Brand Name: POLIDENT DENTURE ADHESIVE MAX COMFORT
• Common Device Name: DENTURE ADHESIVE
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 19834798
• Report Number: 1000415764-2024-00189
• Device Sequence Number: 11794060
• Product Code: KOO
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2025
• Device Lot Number: LV7C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female