MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA); DENTURE ADHESIVE

Lot Number H59M

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Argus case (b)(4).

Event Description

It made me gag and choke.[choking].It made me gag and choke.[gagging].It used to pull my skin out that's how good it used to hold [exfoliation].They hold like 30 minutes.I had to put 9 lines on there for it to hold.These two tubes i have to use them 2-3 times a days because they don't hold [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6)-year-old male patient who received double salt dental adhesive cream (super poligrip extra care (zinc free formula)) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (super poligrip free denture adhesive cream) cream (batch number h59m, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream.On (b)(6) 2019, an unknown time after starting super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream, the patient experienced choking (serious criteria gsk medically significant), gagging, device used for unapproved schedule and product complaint.On an unknown date, the patient experienced exfoliation.The action taken with super poligrip extra care (zinc free formula) was unknown.The action taken with super poligrip free denture adhesive cream was unknown.On an unknown date, the outcome of the choking and gagging were not recovered/not resolved and the outcome of the exfoliation, device used for unapproved schedule and product complaint were unknown.The reporter considered the choking, gagging and exfoliation to be related to super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream.It was unknown if the reporter considered the device used for unapproved schedule to be related to super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream.Additional details, adverse event information was received via call on (b)(6) 2019.Consumer called in about (super poligrip extra care and super poligrip free denture adhesive cream and reported that, "this is the second tube of super poligrip that i bought.I bought some on friday and it was gold looking and today i bought the green looking color.Do you know that your product doesn't hold.The gold one isn't holding and the green one doesn't hold and it made me gag and choke.They hold like 30 minutes.I had to put 9 lines on there for it to hold.When i used to take my dentures out it used to pull my skin out that's how good it used to hold.These two tubes i have to use them 2-3 times a days because they don't hold.".

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 48-year-old male patient who received double salt dental adhesive cream (super poligrip extra care (zinc free formula)) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (super poligrip free denture adhesive cream) cream (batch number h59m, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream.On (b)(6) 2019, an unknown time after starting super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream, the patient experienced choking (serious criteria gsk medically significant), gagging, device used for unapproved schedule and product complaint.On an unknown date, the patient experienced exfoliation.The action taken with super poligrip extra care (zinc free formula) was unknown.The action taken with super poligrip free denture adhesive cream was unknown.On an unknown date, the outcome of the choking and gagging were not recovered/not resolved and the outcome of the exfoliation, device used for unapproved schedule and product complaint were unknown.The reporter considered the choking, gagging and exfoliation to be related to super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream.It was unknown if the reporter considered the device used for unapproved schedule to be related to super poligrip extra care (zinc free formula) and super poligrip free denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, adverse event information was received via call on (b)(6) 2019.Consumer called in about (super poligrip extra care and super poligrip free denture adhesive cream and reported that, "this is the second tube of super poligrip that i bought.I bought some on friday and it was gold looking and today i bought the green looking color.Do you know that your product doesn't hold.The gold one isn't holding and the green one doesn't hold and it made me gag and choke.They hold like 30 minutes.I had to put 9 lines on there for it to hold.When i used to take my dentures out it used to pull my skin out that's how good it used to hold.These two tubes i have to use them 2-3 times a days because they don't hold." follow up information was received on (b)(6) 2019 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for unknown lot number.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample not received at investigation site.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.Follow up information was received on (b)(6) 2019 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for h59m lot number.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample not received at investigation site.A notification review check was carried out on this batch which relates to manufacturing deviations, vendor investigations, change controls and laboratory investigations, there were no issues noted during the manufacture of this batch as per the defect of this complaint received.Therefore no further actions will be taken at this time.

Manufacturer Narrative

Mfr#: 3003721894-2019-00338 is associated with argus case (b)(4).

• Brand Name: SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford; dungarvan, waterford ; EI
• MDR Report Key: 9329051
• MDR Text Key: 208130705
• Report Number: 3003721894-2019-00338
• 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: 11/05/2019

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
• Device Lot Number: H59M
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR