MAUDE Adverse Event Report: ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH POLIGRIP CUSHION COMFORT; DENTURE ADHESIVE

Lot Number N85V

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 id: (b)(4).

Event Description

A piece went down my throat/ it will go down your throat [accidental device ingestion] starts making you choke/ i was afraid i would choke [choking sensation].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), choking sensation and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the accidental device ingestion, choking sensation and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and choking sensation to be related to poligrip cushion comfort.Additional details : the adverse event was received from a consumer via call center representative (email) on 03nov2021.The consumer stated that "this product is horrible.I tried a few and this doesn't hold.It moves in the denture and starts making you choke.I threw it out because a piece went down my throat.I was afraid i would choke.This should be off the market.The product was poligrip comfort and cushion denture cream.It is terrible doesn't hold dentures in place.It slides off dentures gets stuck on the roof of your mouth.It's very embarrassing when you can't take out dentures to remove the product from your mouth.Besides that, it will go down your throat." follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: the complaint case was reviewed and closed by loc qa with complaint conclusion of performed at this time.If additional information is received, the case will be re-opened and updated with the additional information and re-process accordingly.Complaint inconclusive.The lot number is invalid/unknown.No further investigation can be performed this product is produced at multiple manufacturing sites.Follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: the complaint case was reviewed and closed by loc qa with complaint conclusion of performed at this time.If additional information is received, the case will be re-opened and updated with the additional information and re-process accordingly.Complaint inconclusive.The lot number is invalid/unknown.No further investigation can be performed this product is produced at multiple manufacturing sites.Follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.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 and 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.Follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.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 and 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.Initial and follow ups processed together.

Event Description

A piece went down my throat/ it will go down your throat [accidental device ingestion] starts making you choke/ i was afraid i would choke [choking sensation].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), choking sensation and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the accidental device ingestion, choking sensation and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and choking sensation to be related to poligrip cushion comfort.Additional details : the adverse event was received from a consumer via call center representative (email) on 03nov2021.The consumer stated that "this product is horrible.I tried a few and this doesn't hold.It moves in the denture and starts making you choke.I threw it out because a piece went down my throat.I was afraid i would choke.This should be off the market.The product was poligrip comfort and cushion denture cream.It is terrible doesn't hold dentures in place.It slides off dentures gets stuck on the roof of your mouth.It's very embarrassing when you can't take out dentures to remove the product from your mouth.Besides that, it will go down your throat." follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: the complaint case was reviewed and closed by loc qa with complaint conclusion of performed at this time.If additional information is received, the case will be re-opened and updated with the additional information and re-process accordingly.Complaint inconclusive.The lot number is invalid/unknown.No further investigation can be performed this product is produced at multiple manufacturing sites.Follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: the complaint case was reviewed and closed by loc qa with complaint conclusion of performed at this time.If additional information is received, the case will be re-opened and updated with the additional information and re-process accordingly.Complaint inconclusive.The lot number is invalid/unknown.No further investigation can be performed this product is produced at multiple manufacturing sites.Follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.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 and 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.Follow up: qa investigational results: follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4)), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.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 and 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.Initial and follow ups processed together.

Manufacturer Narrative

Argus case id: (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 patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), choking sensation and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the accidental device ingestion, choking sensation and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and choking sensation to be related to poligrip cushion comfort.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details : the adverse event was received from a consumer via call center representative (email) on 03nov2021.The consumer stated that "this product is horrible.I tried a few and this doesn't hold.It moves in the denture and starts making you choke.I threw it out because a piece went down my throat.I was afraid i would choke.This should be off the market.The product was poligrip comfort and cushion denture cream.It is terrible doesn't hold dentures in place.It slides off dentures gets stuck on the roof of your mouth.It's very embarrassing when you can't take out dentures to remove the product from your mouth.Besides that, it will go down your throat." follow up: qa investigational results (1) follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue: (b)(4), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: the complaint case was reviewed and closed by loc qa with complaint conclusion of performed at this time.If additional information is received, the case will be re-opened and updated with the additional information and re-process accordingly.Complaint inconclusive.The lot number is invalid/unknown.No further investigation can be performed this product is produced at multiple manufacturing sites.Follow up: qa investigational results (2) follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: the complaint case was reviewed and closed by loc qa with complaint conclusion of performed at this time.If additional information is received, the case will be re-opened and updated with the additional information and re-process accordingly.Complaint inconclusive.The lot number is invalid/unknown.No further investigation can be performed this product is produced at multiple manufacturing sites.Follow up: qa investigational results (3) follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.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 and 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.Follow up: qa investigational results (4) follow up qa investigational results were received from qa department for product quality complaint (b)(4) (issue : (b)(4), for poligrip cushion and comfort denture fixture 2.2oz (batch no: unk) on 04nov2021.The evaluation results were inconclusive.Investigation evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.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 and 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.Initial and follow ups processed together.Follow up (5) information was received on 03dec2021 from quality assurance department regarding complaint (b)(4) for lot number n85v and unknown expiry date.Patient reported that "i have no box.I dont save things like that.I have a picture of the tube" investigation evaluation: this is the fifth complaint of this nature for this batch.No complaint sample was received to site, however the customer did provide a photo of the complaint sample.However, as this complaint is related to a reported formulation defect, photos are not sufficient to investigate further.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.Should the complaint sample become available the case will be reopened.The investigation reports concluded that the complaint as unsubstantiated.The pqc number was pqc115749.Follow up (6) information was received on 03dec2021 from quality assurance department regarding complaint (b)(4) for lot number n85v and unknown expiry date.Investigation evaluation: this is the second complaint of this nature for this batch.No complaint sample was received to site, however the customer did provide a photo of the complaint sample.However as this complaint is related to a reported formulation defect, photos are not sufficient to investigate further.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.The investigation reports concluded that the complaint as unsubstantiated.The pqc number was pqc115751.The batch number of suspect product was updated from unknown to n85v.Follow up (5) and follow up (6) information were processed together.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: POLIGRIP CUSHION COMFORT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH; oberkirch, baden-wurttemberg ; GM
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 12787202
• MDR Text Key: 285402253
• Report Number: 3003341442-2021-00018
• 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,Followup
• Report Date: 11/03/2021

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 Number: N85V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other