MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT DENTURE ADHESIVE CREAM

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Consumer's usage method is wrong [wrong technique in device usage process], she applied approximately 3 times [device used for unapproved schedule], sometimes gum hurt [gum pain], bleeding when denture bit the side of her tongue [hemorrhage].Case description: this case was reported by a consumer via call center representative and described the occurrence of wrong technique in device usage process in a female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for product used for unknown indication.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced wrong technique in device usage process, device used for unapproved schedule, gum pain and bleeding (serious criteria gsk medically significant).The action taken with polident denture adhesive cream was unknown.On an unknown date, the outcome of the wrong technique in device usage process, device used for unapproved schedule, gum pain and bleeding were unknown.It was unknown if the reporter considered the wrong technique in device usage process, device used for unapproved schedule, gum pain and bleeding to be related to polident denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the action taken with polident denture adhesive cream was unknown.Consumer applied approximately 3 times a day; hence been using dentures for approximately 2 plus years.Would visit the dentist fortnightly as sometimes her gums hurt, so the dentist would assist to apply medication and adjust the dentures.Consumer was also mentioned to the dentist before that the dentures would drop off, and the dentist would just help to adjust and file it and asked her to use the product according to the pictures, did not ask her to increase the use of the adhesive cream.However, she does not just applied the cream quantity like the approximate size of a mung bean, she would spread it out evenly.As compared to previously, the dentures fall off quicker.During a market promotion, a lady asked the consumer to use water to dab first and it would be easier to stick.Hence, consumer followed the lady's methods and the duration of adhesiveness was slightly longer, but not as long as the 12 hours that was claimed on the box.According the product information usage methods and suggested that the consumer should consult a dentist, and let the dentist provide the best recommendation for her situation.Consumer expressed that she was an old customer and hopes that could gave her 1 small tube of adhesive cream for free so that she can kept it in her bag and used it when she was outdoors.Consumer expressed that she did recommend polident denture adhesive cream to her friends.Her friends were not used to it and hence stopped using thereafter.Then she heard from her dentist that without wearing the dentures, the gums would shrink and the dentures would not be suitable anymore.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9580324
• MDR Text Key: 189749483
• Report Number: 3003721894-2019-00394
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

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: No Information
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/13/2020
• 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