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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Lack of efficacy [lack of drug effect].Accidental device ingestion [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of lack of drug effect in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for drug use 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 lack of drug effect and accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant).On an unknown date, the outcome of the lack of drug effect and accidental device ingestion were unknown.It was unknown if the reporter considered the lack of drug effect 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: this case was reported from a consumer via call center representative on (b)(6) 2015.A male consumer born in (b)(6) has used polident denture adhesive cream from an unknown date.The consumer reported that the product did not last for 12 hours and his denture was detached 4 to 5 hours after using the product.No adhesive cream left on his denture hence the consumer suspected that he swallowed the product.The consumer would like to know the reason why the product did not last for 12 hours not like written on the labelling.Moreover, the consumer queried it would be fine if he swallowed the product or used it more than once a day.No further safety information was reported.The consumer did not consent on local privacy law, so no further information would be available.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; knockbrack; dungarvan, waterford ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5332328
• MDR Text Key: 34586880
• Report Number: 3003721894-2015-00050
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other