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

Device Problem Product Quality Problem (1506)

Patient Problem Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

Argus case id (b)(4).

Event Description

I was diagnosed with neuropathy in my feet [neuropathy], i used them for about 10 years and was using it about twice a day [device use issue].Case description: this case was reported by a consumer and described the occurrence of neuropathy in a (b)(6) male patient who received denture adhesive powder-double salt (super poligrip denture adhesive powder) oral powder (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.In 2009, the patient started super poligrip denture adhesive powder.On an unknown date, an unknown time after starting super poligrip denture adhesive powder, the patient experienced neuropathy (serious criteria gsk medically significant), device use issue and product complaint.On an unknown date, the outcome of the neuropathy, device use issue and product complaint were unknown.It was unknown if the reporter considered the neuropathy and device use issue to be related to super poligrip denture adhesive powder.Additional information: adverse event information was received via live call on 02 may 2019.The consumer stated" i am calling in regarding the super poligrip powder.I wanted to know if it has zinc since i don't see it on here.I was diagnosed with neuropathy in my feet.They said it was probably due to zinc and in the (b)(6) couldn't understand why i had it.You took off the market for quite a while i couldn't find it.I like the powder more than the cream.I have a nurse practitioner not a doctor she wouldn't consider looking at the papers.The (b)(6) is not a good place to go.I used them for about 10 years and was using it about twice a day since my dentures were getting loose.I only use it once a day now.Recently i started using it again i have maybe 6 months using it again daily.Like maybe 3 or 4 years i used it twice a day.I wear them for my loose fitting dentures.".

Manufacturer Narrative

Argus case (b)(4).Product quality investigation completed 24 may 2019: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a 'batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.

Event Description

Case description: this case was reported by a consumer and described the occurrence of neuropathy in a 72-year-old male patient who received denture adhesive powder-double salt (super poligrip denture adhesive powder) oral powder (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.In 2009, the patient started super poligrip denture adhesive powder.On an unknown date, an unknown time after starting super poligrip denture adhesive powder, the patient experienced neuropathy (serious criteria gsk medically significant), device use issue and product complaint.On an unknown date, the outcome of the neuropathy, device use issue and product complaint were unknown.It was unknown if the reporter considered the neuropathy and device use issue to be related to 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.Additional information: adverse event information was received via live call on 02 may 2019.The consumer stated" i am calling in regarding the super poligrip powder.I wanted to know if it has zinc since i don't see it on here.I was diagnosed with neuropathy in my feet.They said it was probably due to zinc and in the va couldn't understand why i had it.You took off the market for quite a while i couldn't find it.I like the powder more than the cream.I have a nurse practitioner not a doctor she wouldn't consider looking at the papers.The va is not a good place to go.I used them for about 10 years and was using it about twice a day since my dentures were getting loose.I only use it once a day now.Recently i started using it again i have maybe 6 months using it again daily.Like maybe 3 or 4 years i used it twice a day.I wear them for my loose fitting dentures." follow up information was received on 24 may 2019 from quality assurance (qa) department regarding complaint number (b)(4) (issue number) for lot number unknown.No sample was returned for this complaint, also batch details were not received so a full investigation was not done.As this information was not available the complaint cannot be substantiated.

• Brand Name: SUPER POLIGRIP DENTURE ADHESIVE POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 8619219
• MDR Text Key: 145360420
• Report Number: 3003721894-2019-00125
• 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
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO THERAPY (NO THERAPY); NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 72 YR