MAUDE Adverse Event Report: GSK DUNGARVAN STAFFORD MILLER POLIDENT DENTURE ADHESIVE CREAM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Type  No Answer Provided  

Event Description

Accidental ingestion of product [accidental ingestion of product].Case description: this case was reported by a consumer and described the occurrence of accidental ingestion of product in an (b)(6)-year-old-male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for an unk indication.In 2015, the patient started polident denture adhesive cream, the patient experienced accidental ingestion of product.On an unk date, the outcome of the accidental ingestion of product was unk.It was unk if the reporter considered the accidental ingestion of product to be related to polident denture adhesive cream.

Manufacturer Narrative

Additional info: reporter reported that his father's teeth had been removed recently.He had been using the denture for few days.Dentist recommended him to use this product.It was his first time to use it.He had used 3 dips of products on the lower and upper denture respectively once per day.Reporter enquired that if it was fine to swallow the product when drinking water.Reporter reported that the product may have been swallowed with saliva accidentally when using the dentures.He also reported that the product may have been swallowed accidentally when removing the dentures.His father did not feel discomfort after swallowing the product.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GSK DUNGARVAN STAFFORD MILLER; dungarvan, ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4623001
• MDR Text Key: 5654012
• Report Number: 9681138-2015-00011
• 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: Foreign,Consumer
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/05/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR