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

Lot Number H59M

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case:(b)(4).

Event Description

I am just positive that it is going down my throat.I feel like it is causing or sticking in my passage way [medication stuck in throat].I feel like it is in my throat [throat discomfort] i feel like it is sticking and i am positive that it goes down [exposure via ingestion] this case was reported by a consumer via call center representative and described the occurrence of throat discomfort in a female patient who received double salt dental adhesive cream (super poligrip extra care (zinc free formula)) cream (batch number xe2p, 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 original (zinc free formula)) cream (batch number h59m, expiry date unknown) for denture wearer.Concomitant products included no therapy.In (b)(6) 2019, the patient started super poligrip extra care (zinc free formula) and super poligrip original (zinc free formula).On an unknown date, an unknown time after starting super poligrip extra care (zinc free formula) and super poligrip original (zinc free formula), the patient experienced throat discomfort, medication stuck in throat, exposure via ingestion and product complaint.The action taken with super poligrip extra care (zinc free formula) was unknown.On an unknown date, the outcome of the throat discomfort, medication stuck in throat, exposure via ingestion and product complaint were unknown.The reporter considered the throat discomfort and medication stuck in throat to be related to super poligrip extra care (zinc free formula) and super poligrip original (zinc free formula).It was unknown if the reporter considered the exposure via ingestion to be related to super poligrip extra care (zinc free formula) and super poligrip original (zinc free formula).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 center representative on 18 february 2020.The consumer reported that "i have an upper partial denture and when i removed it after the end of the day the product stays in my mouth.When i use warm water and toothbrush to remove it but feel it is like sticking.I am just positive that it is going down my throat.I feel like it is causing or sticking in my passage way and i believe it is like staying there.I see it in my sink and in the drain and it is sticking.There is no way to dilute it to go away.I feel like it is sticky in my throat and i don't know how to clear it out of me.It just says warm water but it doesn't dilute at all when it is in the sink, in the drain.I use it daily.I find both of them the same thing, they are not dissolving at all.I was going back and forth to see of there is any difference.Usually i use the extra care more but both are the same".Adverse even revision information was received on same day.The consumer reported that "she mentioned that she have been using the product about 4 months ago and have experienced this reaction.She mentioned that she have been using it for 4 months, both extra care and original".I can't swallow as good.This report is being resubmitted to capture corrections.The information was received on 18 february 2020.The event of medication stuck in throat was upgraded to serious (serious gsk medically significant, gsk medically significant).Follow up information was received on 19 february 2020 from quality assurance (qa) department regarding complaint number 00290488 for lot number xe2p.The investigation report included that, sample was not returned for this complaint.Denture adhesive creams were specially formulated to form a tight seal and provided a firm hold for dentures.The combination of the duo salt and carboxymethylcellulose in the product provided the adhesive strength that helped hold dentures in place.Customer complaint was individually investigated whereby the complaint sample was tested for the percentage of active ingredient.The complaint was found to be unsubstantiated.Follow up information was received on 25 february 2020 from quality assurance (qa) department regarding complaint number (b)(4) for lot number h59m.The investigation report included that, sample was not returned for this complaint.Denture adhesive creams were specially formulated to form a tight seal and provided a firm hold for dentures.The combination of the duo salt and carboxymethylcellulose in the product provided the adhesive strength that helped hold dentures in place.Customer complaint was individually investigated whereby the complaint sample was tested for the percentage of active ingredient.The complaint was found to be unsubstantiated.

• Brand Name: SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
• 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: 10926886
• MDR Text Key: 221286635
• Report Number: 3003721894-2020-00337
• 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: 02/18/2020

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 Lot Number: H59M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: No
• 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