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

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

Patient Problem Gastritis (1874)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Adhesive is very difficult to remove and clean, eaten a lot, eaten so much adhesive [accidental device ingestion].Tummy discomfort and unable to pass out gas [abdominal discomfort].Which resulted in consumer having gas [gas in stomach].Which resulted in consumer having tummy discomfort, gas and unable to sleep [sleeplessness].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident denture adhesive cream fresh mint) cream (batch number unk, expiry date unknown) for denture wearer.On an unknown date, the patient started polident denture adhesive cream fresh mint.On an unknown date, an unknown time after starting polident denture adhesive cream fresh mint, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medical significant), intercepted medication error, overdose, abdominal discomfort, gas in stomach and sleeplessness.The action taken with polident denture adhesive cream fresh mint was unknown.On an unknown date, the outcome of the accidental device ingestion, intercepted medication error, overdose, abdominal discomfort and sleeplessness were unknown and the outcome of the gas in stomach was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion, abdominal discomfort, gas in stomach and sleeplessness to be related to polident denture adhesive cream fresh mint.Additional details: a few months ago, consumer went to the dentist to get dentures made.The dentist gave him one tube of 8.5g of polident denture adhesive cream fresh mint, then the dentist helped him apply the adhesive, but he was very surprised at the usage and dosage that the dentist applied.The dentist squeezed a strip of about 2 cm into the groove of his denture, then squeezed back and forth on the dentures, for a total of 3 layers of adhesive, it was a thick layer.At that time, he asked the dentist many times if it was alright to apply the adhesive that way, would it be not too thick.The dentist told him that this amount was normal, there was no problem with it.The adhesive strength was very good, not bad, after application.However, after applying in the night his tummy was very uncomfortable, there was gas, unable to pass out; and was unable to sleep at night.He was unable to pass out the gas, which was only fixed by the doctor on the next day, when he went to the hospital to take an ultrasound.After he drank a bowl of porridge, the gas symptom then recovered.Now it had been 2 to 3 months, but he always had a psychological barrier, he did not dare to use adhesive.Like this, after the dentist applied for him, he had eaten so much adhesive, asked would it cause any health problems.The dentist had applied excessive quantity for him, so the adhesiveness was very good.At that time, it was very difficult to remove and clean.Call center representative pacified consumer multiple times and explained the product's method of use, also the precautions during use.Consumer finally understood at the end, indicated that he would use it in accordance with the contents explained and taught.The hook of the denture which was used to hold onto the real teeth had broken, so brought up courage to use it once today, he used it without drying the dentures.He saw the question and answer on the product information leaflet, which stated that it can only be used once a day.However, he need to apply adhesive for all three meals; it was impossible to use it only once a day.After eating, there was a need to rinse the mouth, also may need to take an afternoon nap or something.He asked how can he wear it all the time, would definitely take it off.When it was taken down and left there, it would definitely not be sticky anymore, so he had to use it again.He had not done so yet, just called to ask if it can be used like this.The caller insisted on knowing if he used it three times a day, will it affect his health.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM FRESH MINT
• 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: 10430329
• MDR Text Key: 208131870
• Report Number: 3003721894-2020-00235
• 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,foreign
• Type of Report: Initial
• Report Date: 08/10/2020

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: 08/10/2020
• Initial Date FDA Received: 08/20/2020
• 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