MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP POWER MAX HOLD+SEAL DENTURE ADHESIVE

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

My mouth burned for over a day, it literally had my mouth on fire [burned mouth].My lips burned for over a day [burning lips].It literally had my mouth beefy red [oral redness].I used that one time for 1hr [device used for unapproved schedule].Case description: this case was reported by a consumer via interactive digital media (facebook) and described the occurrence of burned mouth in a patient who received double salt dental adhesive cream (poligrip power max hold+seal denture adhesive) cream for product used for unknown indication.On an unknown date, the patient started poligrip power max hold+seal denture adhesive.On an unknown date, an unknown time after starting poligrip power max hold+seal denture adhesive, the patient experienced burned mouth (serious criteria gsk medically significant and other: gsk medically significant), burning lips, oral redness and device used for unapproved schedule.The action taken with poligrip power max hold+seal denture adhesive was unknown.On an unknown date, the outcome of the burned mouth, burning lips, oral redness and device used for unapproved schedule were unknown.It was unknown if the reporter considered the burned mouth, burning lips, oral redness and device used for unapproved schedule to be related to poligrip power max hold+seal denture adhesive.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from a consumer via interactive digital media (facebook) on (b)(6) 2022.It was reported as; "i used that one time for 1hr and my mouth and lips burned for over a day.It literally had my mouth beefy red and on fire.Threw it away and went back to my old adhesive.Use with caution.".

• Brand Name: POLIGRIP POWER MAX HOLD+SEAL DENTURE ADHESIVE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 14790942
• MDR Text Key: 295040098
• Report Number: 3003721894-2022-00094
• 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: 06/17/2022

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 06/23/2022
• 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: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other