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

Lot Number A37X

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem Choking (2464)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

# 3003721894-2018-00269 is associated with (b)(4) super poligrip original (zinc free formula).

Event Description

Continues to come down my throat.[accidental device ingestion].I gag and choke because it oozes [choking].I gag and choke because it oozes [gagging].I have to apply the original more than once a day [device use error].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6)-year-old female patient who received double salt dental adhesive cream (super poligrip free denture adhesive cream) 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 original (zinc free formula)) cream (batch number a37x, expiry date unknown) for denture wearer.Concurrent medical conditions included smoker.Concomitant products included no therapy.On (b)(6) 2018, the patient started super poligrip free denture adhesive cream and super poligrip original (zinc free formula).On (b)(6) 2018, less than a day after starting super poligrip free denture adhesive cream and super poligrip original (zinc free formula), the patient experienced accidental device ingestion (serious criteria gsk medically significant), choking (serious criteria gsk medically significant), gagging, device use error and product complaint.On (b)(6) 2018, the outcome of the choking and gagging were recovered/resolved.On an unknown date, the outcome of the accidental device ingestion, device use error and product complaint were unknown.The reporter considered the accidental device ingestion, choking and gagging to be related to super poligrip free denture adhesive cream.It was unknown if the reporter considered the device use error to be related to super poligrip free denture adhesive cream and super poligrip original (zinc free formula).It was unknown if the reporter considered the accidental device ingestion, choking and gagging to be related to super poligrip original (zinc free formula).Additional information: adverse event information was received on 24 july 2018.Consumer stated, "i would like to see on the shelves of stores a variety pack of all three polident - i purchase all three and have to buy different boxes of all three types and think a variety pack would be a good idea.I love the product and they work very well.I am a smoker and i love the cinnamon.I use each of the products at a different time.I also use the poligrip.I wish there was a way to fix that it doesn't ooze that much from my dentures.I gag and choke because it oozes and continues to come down my throat.I wish it would last longer through the day.What is the zinc for? i have to apply the original more than once a day.The green one seems to last longer.Are you supposed to apply it when they're dry? i used to use the fixodent and that oozes badly, that's why i switched over".

Manufacturer Narrative

Argus case: (b)(4) super poligrip original (zinc free formula).Qa investigation is ongoing for super poligrip original.Qa results are pending.

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a 59-year-old female patient who received double salt dental adhesive cream (super poligrip free denture adhesive cream) 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 original (zinc free formula)) cream (batch number: a37x, expiry date unknown) for denture wearer.Concurrent medical conditions included smoker.Concomitant products included no therapy.On (b)(6) 2018, the patient started super poligrip free denture adhesive cream and super poligrip original (zinc free formula).On (b)(6) 2018, less than a day after starting super poligrip free denture adhesive cream and super poligrip original (zinc free formula), the patient experienced accidental device ingestion (serious criteria gsk medically significant), choking (serious criteria gsk medically significant), gagging, device use error and product complaint.On (b)(6) 2018, the outcome of the choking and gagging were recovered/resolved.On an unknown date, the outcome of the accidental device ingestion, device use error and product complaint were unknown.The reporter considered the accidental device ingestion, choking and gagging to be related to super poligrip free denture adhesive cream.It was unknown if the reporter considered the device use error to be related to super poligrip free denture adhesive cream and super poligrip original (zinc free formula).It was unknown if the reporter considered the accidental device ingestion, choking and gagging to be related to 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.Additional information, adverse event information was received on (b)(6) 2018.Consumer stated, "i would like to see on the shelves of stores a variety pack of all three polident - i purchase all three and have to buy different boxes of all three types and think a variety pack would be a good idea.I love the product and they work very well.I am a smoker and i love the cinnamon.I use each of the products at a different time.I also use the poligrip.I wish there was a way to fix that it doesn't ooze that much from my dentures.I gag and choke because it oozes and continues to come down my throat.I wish it would last longer through the day.What is the zinc for? i have to apply the original more than once a day.The green one seems to last longer.Are you supposed to apply it when they're dry? i used to use the fixodent and that oozes badly, that's why i switched over".Adverse event revision information was received on (b)(6) 2018.Consumer used the super poligrip to hold in her dentures.It oozes out from between her gums and dentures.This oozing causes her to gag, choke and accidentally ingest the product.This product also does not hold her dentures in, causing her to re-apply it.Follow-up information was received on 14 august 2018 from the quality assurance (qa) department regarding issue: (b)(4) for unknown lot number.No sample was returned for this complaint and also the batch details were not received so a full investigation could not be completed.Qa analysis revealed the complaint to be unsubstantiated.

Manufacturer Narrative

Initial report is associated with argus case (b)(4) super poligrip original (zinc free formula).Qa investigation (issue-(b)(4): product does not hold) 23 aug 2018: this is the first complaint of this nature for this batch, this is within the upper control limit.The analytical release data was reviewed by quality and all results were within specification requirements for this batch.Stability data confirms that the product remains within specification for the duration of the shelf life for this product.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.

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a 59-year-old female patient who received double salt dental adhesive cream (super poligrip free denture adhesive cream) 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 original (zinc free formula)) cream (batch number a37x, expiry date unknown) for denture wearer.Concurrent medical conditions included smoker.Concomitant products included no therapy.On (b)(6) 2018, the patient started super poligrip free denture adhesive cream and super poligrip original (zinc free formula).On (b)(6) 2018, less than a day after starting super poligrip free denture adhesive cream and super poligrip original (zinc free formula), the patient experienced accidental device ingestion (serious criteria gsk medically significant), choking (serious criteria gsk medically significant), gagging, device use error and product complaint.On (b)(6) 2018, the outcome of the choking and gagging were recovered/resolved.On an unknown date, the outcome of the accidental device ingestion, device use error and product complaint were unknown.The reporter considered the accidental device ingestion, choking and gagging to be related to super poligrip free denture adhesive cream.It was unknown if the reporter considered the device use error to be related to super poligrip free denture adhesive cream and super poligrip original (zinc free formula).It was unknown if the reporter considered the accidental device ingestion, choking and gagging to be related to 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.Additional information: adverse event information was received on (b)(6) 2018.Consumer stated, "i would like to see on the shelves of stores a variety pack of all three polident - i purchase all three and have to buy different boxes of all three types and think a variety pack would be a good idea.I love the product and they work very well.I am a smoker and i love the cinnamon.I use each of the products at a different time.I also use the poligrip.I wish there was a way to fix that it doesn't ooze that much from my dentures.I gag and choke because it oozes and continues to come down my throat.I wish it would last longer through the day.What is the zinc for? i have to apply the original more than once a day.The green one seems to last longer.Are you supposed to apply it when they're dry? i used to use the fixodent and that oozes badly, that's why i switched over".Adverse event revision information was received on 03 august 2018.Consumer used the super poligrip to hold in her dentures.It oozes out from between her gums and dentures.This oozing causes her to gag, choke and accidentally ingest the product.This product also does not hold her dentures in, causing her to re-apply it.Follow-up information was received on 14 august 2018 from the quality assurance (qa) department regarding issue (b)(4) for unknown lot number.No sample was returned for this complaint and also the batch details were not received so a full investigation could not be completed.Qa analysis revealed the complaint to be unsubstantiated.Follow-up information was received on 23 august 2018 from the quality assurance (qa) department regarding issue (b)(4) for lot number a37x.The quality investigation report concluded that, the product sample was not received and the analytical release data was reviewed by quality and all results were within specification requirements for this batch.Stability data confirms that the product remains within specification for the duration of the shelf life for this product.The product complaint was closed as unsubstantiated.The event onset date was removed for the device use error and product complaint.

• Brand Name: SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 7748968
• MDR Text Key: 116043018
• Report Number: 3003721894-2018-00269
• 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,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: A37X
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR