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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); UNKNOWN
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GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); UNKNOWN Back to Search Results
Lot Number 3S5Y
Device Problem Product Quality Problem (1506)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
Argus case (b)(4).
 
Event Description
Other question i have is swallowing the product / this happened last night.[accidental device ingestion].I tried to used a toothbrush to remove it and tried to remove it from sachets and i ended up with a mouth full of blood.[mouth hemorrhage].I tried to used a toothbrush to remove it and tried to remove it from sachets [wrong technique in device usage process].Its just that my gums are really not completely heal [gingival injury].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) year-old male patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number 3s5y, expiry date unknown) for dental care.This case was associated with a product complaint.Concurrent medical conditions included irritable bowel syndrome.Concomitant products included no therapy.On (b)(6) 2021, the patient started super poligrip original (zinc free formula).On (b)(6) 2021, an unknown time after starting super poligrip original (zinc free formula), the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), mouth hemorrhage, wrong technique in device usage process and gingival injury.On an unknown date, the patient experienced product complaint.The action taken with super poligrip original (zinc free formula) was unknown.On (b)(6) 2021, the outcome of the mouth hemorrhage was recovered/resolved.On an unknown date, the outcome of the accidental device ingestion, wrong technique in device usage process and product complaint were unknown and the outcome of the gingival injury was recovering/resolving.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to super poligrip original (zinc free formula).The reporter considered the mouth hemorrhage and gingival injury 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: the case was reported via call center representative on 15 jan 2021.The consumer reported that "super poligrip original 2.4 oz i am new to dentures and i am trying to get used to wear them.I tried some poligrip last night and it helped with the cushioning of the dentures because they were hurting and when i removed my dentures after 6 hours and to find that pink stuff, it was all stuck to the roof of my mouth and gums and i had to use mouthwash, paper towels, water and it won't come out.How do you get it out of your mouth? i tried to used a toothbrush to remove it and tried to remove it from sachets and i ended up with a mouth full of blood.They are not completely seal from the teeth i got pull out.It doesn't have to do with your product.It as just that my gums are really not completely heal.Other question i have is swallowing the product, are there any side effects like constipation or anything like that? i have ibs and i don't need anything that gets it worse.I take a lot medication.This happened last night.This is the first time using it.I hope you can come up with a mouthwash to remove it and make it easier for people".
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 55-year-old male patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number 3s5y, expiry date unknown) for dental care.This case was associated with a product complaint.Concurrent medical conditions included irritable bowel syndrome.Concomitant products included no therapy.On (b)(6) 2021, the patient started super poligrip original (zinc free formula).On (b)(6) 2021, an unknown time after starting super poligrip original (zinc free formula), the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), mouth hemorrhage, wrong technique in device usage process and gingival injury.On an unknown date, the patient experienced product complaint.The action taken with super poligrip original (zinc free formula) was unknown.On (b)(6) 2021, the outcome of the mouth hemorrhage was recovered/resolved.On an unknown date, the outcome of the accidental device ingestion, wrong technique in device usage process and product complaint were unknown and the outcome of the gingival injury was recovering/resolving.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to super poligrip original (zinc free formula).The reporter considered the mouth hemorrhage and gingival injury 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: the case was reported via call center representative on 15 jan 2021.The consumer reported that "super poligrip original 2.4 oz i am new to dentures and i am trying to get used to wear them.I tried some poligrip last night and it helped with the cushioning of the dentures because they were hurting and when i removed my dentures after 6 hours and to find that pink stuff, it was all stuck to the roof of my mouth and gums and i had to use mouthwash, paper towels, water and it won't come out.How do you get it out of your mouth? i tried to used a toothbrush to remove it and tried to remove it from sachets and i ended up with a mouth full of blood.They are not completely seal from the teeth i got pull out.It doesn't have to do with your product.It as just that my gums are really not completely heal.Other question i have is swallowing the product, are there any side effects like constipation or anything like that? i have ibs and i don't need anything that gets it worse.I take a lot medication.This happened last night.This is the first time using it.I hope you can come up with a mouthwash to remove it and make it easier for people".Follow up information was received via quality investigators on 28 jan 2021.The product complaint was identified as unsubstantiated investigation evaluation: this is the first complaint of this nature for this batch.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
Argus case (b)(4).
 
Manufacturer Narrative
Argus case: (b)(4).
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 55-year-old male patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number 3s5y, expiry date unknown) for dental care.This case was associated with a product complaint.Concurrent medical conditions included irritable bowel syndrome.Concomitant products included no therapy.On (b)(6) 2021, the patient started super poligrip original (zinc free formula).On (b)(6) 2021, an unknown time after starting super poligrip original (zinc free formula), the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), mouth hemorrhage, wrong technique in device usage process and gingival injury.On an unknown date, the patient experienced product complaint.The action taken with super poligrip original (zinc free formula) was unknown.On (b)(6) 2021, the outcome of the mouth hemorrhage was recovered/resolved.On an unknown date, the outcome of the accidental device ingestion, wrong technique in device usage process and product complaint were unknown and the outcome of the gingival injury was recovering/resolving.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to super poligrip original (zinc free formula).The reporter considered the mouth hemorrhage and gingival injury 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: the case was reported via call center representative on 15 jan 2021.The consumer reported that "super poligrip original 2.4 oz i am new to dentures and i am trying to get used to wear them.I tried some poligrip last night and it helped with the cushioning of the dentures because they were hurting and when i removed my dentures after 6 hours and to find that pink stuff, it was all stuck to the roof of my mouth and gums and i had to use mouthwash, paper towels, water and it won't come out.How do you get it out of your mouth? i tried to used a toothbrush to remove it and tried to remove it from sachets and i ended up with a mouth full of blood.They are not completely seal from the teeth i got pull out.It doesn't have to do with your product.It as just that my gums are really not completely heal.Other question i have is swallowing the product, are there any side effects like constipation or anything like that? i have ibs and i don't need anything that gets it worse.I take a lot medication.This happened last night.This is the first time using it.I hope you can come up with a mouthwash to remove it and make it easier for people".Follow up information was received via quality investigators on 28 jan 2021.The product complaint was identified as unsubstantiated investigation evaluation: this is the first complaint of this nature for this batch.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.Follow up information was received from quality investigators on 8 march 2021.Product complaint was concluded as unsubstantiated investigation evaluation: this is the first complaint of this nature for this batch.The complaint and retain sample was received on site and sent to the lab for testing.The testing of the retain sample has met the required quality standards.
 
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Brand Name
SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
Type of Device
UNKNOWN
Manufacturer (Section D)
GLAXOSMITHKLINE DUNGARVAN LTD
dungarvan
waterford,
EI 
MDR Report Key11228626
MDR Text Key230989111
Report Number3003721894-2021-00021
Device Sequence Number1
Product Code KOT
Combination Product (y/n)Y
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 01/15/2021
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 Number3S5Y
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received01/28/2021
03/08/2021
Supplement Dates FDA Received02/11/2021
04/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO THERAPY (NO THERAPY).
Patient Outcome(s) Other;
Patient Age55 YR
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