BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT ANTIBACTERIAL DENTURE CLEANSER 3 MINUTE DAILY CLEANSER

    MDR report key: 9733559 · Received February 19, 2020

    Report

    Report Number
    MW5093129
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    February 16, 2020
    Report Date
    February 17, 2020
    Manufacturer
    GSK CONSUMER HEALTHCARE HOLDINGS (US) LLC
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE OCTOBER HAD BEEN USING POLIDENT 4 MIN DAILY CLEANSER AS DIRECTED ON A DENTAL DEVICE, I WEAR AT NIGHT AS RECOMMENDED BY MY DENTAL OFFICE. EXPERIENCED BURNING SENSATION ON MY TONGUE AND TONGUE BLEEDING FOR SEVERAL WEEKS. SYMPTOMS RESOLVED AFTER DISCONTINUING USE OF POLIDENT FOR CLEANING. I USED POLIDENT AGAIN ONCE TO CLEAN MY DEVICE AND EXPERIENCED SAME SYMPTOMS AFTER ONE NIGHT OF WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191901 POLIDENT ANTIBACTERIAL DENTURE CLEANSER 3 MINUTE DAILY CLEANSER CLEANSER, DENTURE, OVER THE COUNTER EFT GSK CONSUMER HEALTHCARE HOLDINGS (US) LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR