MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT ADHESIVE FRESHMINT; DENTURE ADHESIVE

Lot Number SF9F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), polident adhesive freshmint.Polident adhesive freshmint is marketed as super poligrip in the us.

Event Description

Passed away [unknown cause of death].Potential use of expired product [expired drug used].Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a male patient who received double salt dental adhesive cream (polident adhesive freshmint) cream (batch number sf9f, expiry date 30th november 2018) for drug use for unknown indication.On an unknown date, the patient started polident adhesive freshmint at an unknown dose and frequency.On an unknown date, an unknown time after starting polident adhesive freshmint, the patient experienced death nos (serious criteria death and gsk medically significant) and expired drug used.The action taken with polident adhesive freshmint was unknown.On an unknown date, the outcome of the death nos was fatal and the outcome of the expired drug used was unknown.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos to be related to polident adhesive freshmint.Additional details: the reporter's husband used the product and he's just passed away unfortunately.The reporter says, possibly the product might be out of date because he's been gone a couple of months and he had dentures.The reporter's husband used the product when he was alive.The potential use of expired product was entered conservatively as it was not clear whether the patient used the product after the expiry date.Case was linked to (b)(4) as same reporter.

• Brand Name: POLIDENT ADHESIVE FRESHMINT
• 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: 8301692
• MDR Text Key: 134899317
• Report Number: 3003721894-2019-00031
• 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: 01/29/2019

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
• Device Expiration Date: 11/30/2018
• Device Lot Number: SF9F
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/04/2019
• 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): Death; Other