MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP DENTURE ADHESIVE POWDER

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

Patient Problem Seizures (2063)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

Mfr# 3003721894-2020-00004 is associated with argus case (b)(4).

Event Description

I have allergies and have been having seizures/i was in the hospital because of it and got all kind of tests done [seizure] these seizures i am having wake me up at 4am and go on for about 4 hours [sleep disturbance] my allergies have gotten worse as i got older [allergy aggravated].Case description: this case was reported by a consumer and described the occurrence of seizure in a (b)(6) female patient who received denture adhesive powder-double salt (super poligrip denture adhesive powder) oral powder (batch number y24w, expiry date 31st may 2021) for denture wearer.Co-suspect products included denture adhesive powder-double salt (super poligrip denture adhesive powder) oral powder (batch number unk, expiry date unknown) for denture wearer.Concurrent medical conditions included reaction to azo-dyes (my allergies have gotten worse as i got older).Concomitant products included no therapy.On an unknown date, the patient started super poligrip denture adhesive powder and super poligrip denture adhesive powder.On (b)(6) 2018, an unknown time after starting super poligrip denture adhesive powder and super poligrip denture adhesive powder, the patient experienced seizure (serious criteria hospitalization and gsk medically significant) and sleep disturbance.On an unknown date, the patient experienced allergy aggravated.The action taken with super poligrip denture adhesive powder was unknown.On an unknown date, the outcome of the seizure, sleep disturbance and allergy aggravated were unknown.The reporter considered the seizure to be possibly related to super poligrip denture adhesive powder and super poligrip denture adhesive powder.It was unknown if the reporter considered the sleep disturbance and allergy aggravated to be related to super poligrip denture adhesive powder and super poligrip denture adhesive powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Adverse event information was received via call on 30 december 2019.The consumer reported that "i am an elderly person.I have used super poligrip for a long time.I have allergies and have been having seizures.Is there anything in it that could cause seizures? this is the best product i have been able to use.Is there something in there that has a sea food product or red dye? i am highly allergic to red dye.I also use efferdent to clean the dentures.I have been using it quite a few years; the super poligrip.My allergies have gotten worse as i got older.These seizures i am having wake me up at 4 am and go on for about 4 hours.I was in the hospital because of it and got all kind of tests done.They did tests on my brain and they couldn't find anything wrong.The seizures started about a year ago.I thought it could either be the super poligrip or the efferdent i use".The suspect product included efferdent.The reporter considered the seizure to be possibly related to efferdent.

• Brand Name: SUPER POLIGRIP DENTURE ADHESIVE POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9607331
• MDR Text Key: 189766640
• Report Number: 3003721894-2020-00004
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2019

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: No Information
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/20/2020
• 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): Hospitalization; Other
• Patient Age: 88 YR