MAUDE Adverse Event Report: EQUATE ANTIBACTERIAL MINT FRESH DENTURE CLEANSER TAB

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Injury (2348); Reaction (2414)

Event Type  Injury  

Event Description

Broke out into sores in mouth and tongue.After using this denture cream, she rinsed dentures; the product was so strong it caused a breakout of sores on tongue and mouth.Says the product does not have an ingredient list.She contacted the company and was told it does not have to list ingredients for nonfoods.She contacted (b)(6).A person from (b)(6) read her the ingredients which lists sulfate.She is allergic to sulfates and would not have purchased if she'd known.Use of product was discontinued and several days later her mouth healed.

• Brand Name: EQUATE ANTIBACTERIAL MINT FRESH DENTURE CLEANSER TAB
• Type of Device: EQUATE ANTIBACTERIAL MINT FRESH DENTURE CLEANSER TAB
• MDR Report Key: 6767251
• MDR Text Key: 81916404
• Report Number: MW5071376
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2017

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?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1