MAUDE Adverse Event Report: POLIDENT FREE DENTURE ADHESIVE CREAM

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

Patient Problems Dyspnea (1816); Burning Sensation (2146)

Event Date 03/20/2024

Event Type  Injury  

Manufacturer Narrative

Veeva case: (b)(4).

Event Description

I felt something in my throat, so i put my finger in and found it to be lumpy/it appears that polident is attached [foreign body in throat] my stomach feels hot [stomach burning sensation of] accompanied by a deterioration in his voice [voice disturbance] my mouth is so dry [dry mouth] i struggle to breath [difficulty breathing] stiffness in the uvula area./the area around my uvula is tingling [uvula pain] when trying to expel phlegm, it feels as though it won't come out [throat discomfort] case description: on 2024-03-22 a spontaneous case was reported in korea (the republic of) by a(n) consumer or other non health professional.The report concerns a(n) male consumer.The consumer received polident free denture adhesive cream (carna+polma cream) for indication(s) drug used for unknown indication for an unknown indication for an unknown indication.The consumer's concomitant medication(s) includes:no therapy.On (b)(6) 2024,after an unknown time of starting polident free denture adhesive cream,the consumer experienced a medically significant i felt something in my throat, so i put my finger in and found it to be lumpy/it appears that polident is attached.The outcome of the event i felt something in my throat, so i put my finger in and found it to be lumpy/it appears that polident is attached was unknown.On (b)(6) 2024, and (b)(6) 2024, the consumer experienced a non serious stiffness in the uvula area./the area around my uvula is tingling, and when trying to expel phlegm, it feels as though it won't come out, (preferred term: oral pain, and oropharyngeal discomfort).On an unknown date, the consumer experienced a non serious my stomach feels hot, accompanied by a deterioration in his voice, my mouth is so dry, and i struggle to breath, (preferred term: dyspepsia, dysphonia, dry mouth, and dyspnoea).The outcome of the event my stomach feels hot, accompanied by a deterioration in his voice, my mouth is so dry, i struggle to breath, stiffness in the uvula area./the area around my uvula is tingling, and when trying to expel phlegm, it feels as though it won't come out was unknown.No medical history was reported.No drug history was reported.No comments provided by the reporter.The action(s) taken were: for polident free denture adhesive cream was not reported.Case product: polident free denture adhesive cream device mfr number: 1000415764-2024-00003.

• Brand Name: POLIDENT FREE DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 19141860
• MDR Text Key: 340566980
• Report Number: 1000415764-2024-00003
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Sex: Male