MAUDE Adverse Event Report: POLIDENT; DENTURE CLEANSER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Swelling (2091); Skin Tears (2516)

Event Date 12/08/2015

Event Type  Injury  

Event Description

Properly used efferdent to soak my full dentures, started developing sores within my mouth, lips, etc., like a rash with blisters, cracking skin, pain, etc.Then tried polident, as i had been told it had less of the chemical in it, but the same thing happened.Now it has been several days, my mouth is somewhat better, but as soon as i put the dentures in, it starts all over again, even though i'm not soaking them in those products.I don't know how to rid my dentures of the chemicals.Dates of use: (b)(6) 2015.Diagnosis or reason for use: denture cleaners.

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• MDR Report Key: 5347470
• MDR Text Key: 35242310
• Report Number: MW5058914
• Device Sequence Number: 2
• Product Code: EFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/01/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 59