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

Lot Number 252449

Device Problem Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

07 february 2021: initial report filed under manufacturer number 3003341442-2021-00003, has since been changed to 3003341442-2021-00004.All follow up reports will be submitted under the current manufacturer number of 3003341442-2021-00004.

Event Description

It starts to bleed on the to try to roof of my mouth remove the adhesive.[mouth hemorrhage].This product is not very good.It does not hold my dentures.After 2 to 3 hours after started loosing the grip.Everytime i try to remove it keeps on sticking on my gums on the roof of my mouth [product complaint].Case description: this case was reported by a consumer via call center representative and described the occurrence of mouth hemorrhage in a male patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 252449, expiry date 24th october 2021) for dental care.This case was associated with a product complaint.Concomitant products included no therapy.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 mouth hemorrhage (serious criteria gsk medically significant and other: gsk medically significant) and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the mouth hemorrhage was recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the mouth hemorrhage 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 information adverse event information was received on 13 january 2021 via call center representative.Consumer reported that, "this product is not very good.It does not hold my dentures.After 2 to 3 hours after started losing the grip.Every time i try to remove, it keeps on sticking on my gums on the roof of my mouth.It starts to bleed on the roof of my mouth to try to remove the adhesive".

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of mouth hemorrhage in a male patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 252449, expiry date 24th october 2021) for dental care.This case was associated with a product complaint.Concomitant products included no therapy.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 mouth hemorrhage (serious criteria gsk medically significant and other: gsk medically significant) and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the mouth hemorrhage was recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the mouth hemorrhage 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 information adverse event information was received on 13 january 2021 via call center representative.Consumer reported that, "this product is not very good.It does not hold my dentures.After 2 to 3 hours after started losing the grip.Every time i try to remove, it keeps on sticking on my gums on the roof of my mouth.It starts to bleed on the roof of my mouth to try to remove the adhesive".Follow up information was received on 05 feb 2021 and 11 feb 2021 from quality assurance (qa) department regarding complaint (b)(4) for lot number 252449.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample received at investigation site.The complaint sample was visually inspected and no abnormalities were found.The batch documentation of complaint samples was checked and no deviations found which could have a negative impact to the adhesive strength.Follow up information was received on 13 jan 2021 from quality assurance (qa) department regarding complaint (b)(4) for lot number 252449.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample received at investigation site.The adhesive strength in the lot/product in question was within specification and met all requirements of the release specification.This review also verifies that all test results meet specification requirements.As with any product, it is expected that the consumer may have different experiences based on various individual factors like the fit of the denture and the oral anatomy of the denture wearer, that may determine the performance of the denture adhesive.

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 mouth hemorrhage in a male patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 252449, expiry date 24th october 2021) for dental care.This case was associated with a product complaint.Concomitant products included no therapy.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 mouth hemorrhage (serious criteria gsk medically significant and other: gsk medically significant) and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the mouth hemorrhage was recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the mouth hemorrhage 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 information: adverse event information was received on 13 january 2021 via call center representative.Consumer reported that, "this product is not very good.It does not hold my dentures.After 2 to 3 hours after started losing the grip.Every time i try to remove, it keeps on sticking on my gums on the roof of my mouth.It starts to bleed on the roof of my mouth to try to remove the adhesive".Follow up information was received on 05 feb 2021 and 11 feb 2021 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for lot number unknown.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample received at investigation site.The complaint sample was visually inspected and no abnormalities were found.The batch documentation of complaint samples was checked and no deviations found which could have a negative impact to the adhesive strength.

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
• MDR Report Key: 11292619
• MDR Text Key: 234410473
• Report Number: 3003341442-2021-00004
• 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: 01/13/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2021
• Device Lot Number: 252449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/05/2021; 01/13/2021
• Supplement Dates FDA Received: 03/11/2021; 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other