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

Argus case: us2021008771.

Event Description

It starts to bleed on the to try to rroof of my mouth emove the adhesive.[mouth hemorrhage] 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".

• 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: 11203014
• MDR Text Key: 227828225
• Report Number: 3003341442-2021-00003
• 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: 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: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other