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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Asthma (1726)

Event Type  Injury  

Event Description

Astham crisis (asthmatic crisis).Case description: this case was reported by a dentist via call center representative and described the occurrence of asthmatic crisis in a (b)(6) male patient who received polident (polident (unk) unknown for dental care.On an unknown date, the patient started polident (unk).On an unknown date, an unknown time after starting polident (unk), the patient experienced asthmatic crisis (serious criteria gsk medically significant).On an unknown date, the outcome of the asthmatic crisis was unknown.It was unknown if the reporter considered the asthmatic crisis to be related to polident (unk).Follow-up information was received on 27 february 2015.The reporter confirmed that the product she prescribed was an unspecified polident adhesive cream (not the cleanser) and the suspect product was updated to polident adhesive cream.

Manufacturer Narrative

This report was originally submitted to manufacturer number 1020379-2015-00007 as polident denture cleanser.Upon follow-up, the suspect product was determined to polident adhesive cream.Thus, all future follow-up information will be submitted to manufacturer number 9681138-2015-00008.

• 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: p.o box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4679625
• MDR Text Key: 5689756
• Report Number: 9681138-2015-00008
• 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,Health Professional
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/27/2015
• 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
• Patient Age: 89 YR