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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

It is swallowed in small amounts while being used.[accidental device ingestion].Gastric mucosa was damaged [gastrointestinal mucosal disorder].These days his stomach hurt, and he had a gastroscopy [stomach pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of gastric mucosa erosion in a male patient who received double salt dental adhesive cream (polident free denture adhesive cream) cream for denture wearer.Concurrent medical conditions included gastroscopy.Concomitant products included no therapy.On an unknown date, the patient started polident free denture adhesive cream.On an unknown date, an unknown time after starting polident free denture adhesive cream, the patient experienced gastric mucosa erosion (serious criteria gsk medically significant and other: gsk medically significant), accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), stomach pain and product complaint.The action taken with polident free denture adhesive cream was unknown.On an unknown date, the outcome of the gastric mucosa erosion, accidental device ingestion, stomach pain and product complaint were unknown.It was unknown if the reporter considered the gastric mucosa erosion, accidental device ingestion and stomach pain to be related to polident free denture adhesive cream.Additional details: as reported polident free denture adhesive cream was used to attach the dentures.Since the adhesive cream was thin and had no adhesive power, it was swallowed in small amounts while being used.Consumer didn't knew if it was due to the adhesive cream, but those days his stomach hurt, and he had a gastroscopy.The gastric mucosa was damaged.The consumer received a prescription for medicines from the hospital.

• Brand Name: POLIDENT FREE 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, NC 27709 ; 8888255249
• MDR Report Key: 10301389
• MDR Text Key: 207924687
• Report Number: 3003721894-2020-00184
• 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: 06/22/2020

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: 06/22/2020
• Initial Date FDA Received: 07/21/2020
• 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