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

Device Problem Human-Device Interface Problem (2949)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Other  

Event Description

Device dependence [dependence].Possible device ingestion [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of dependence in a female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.Additional patient notes included she had no allergy or other disease history.In 2013, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced dependence (serious criteria gsk medically significant) and accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the dependence was not recovered/not resolved and the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the dependence and accidental device ingestion to be related to polident denture adhesive cream.Additional information: the consumer used polident cream for one or two years (around 2013).The patient used it before each meal (3 times daily) because she felt the cream was washed away after meal.The patient dared not to eat food if not using the cream, and felt that she developed dependence on it.The patient had cancer screen and confirmed no cancer disease a few days ago.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5145103
• MDR Text Key: 28599442
• Report Number: 3003721894-2015-00011
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 09/16/2015
• 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