BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT

    MDR report key: 11595263 · Received March 30, 2021

    Report

    Report Number
    MW5100407
    Event Type
    Injury
    Date Received
    March 30, 2021
    Report Date
    March 28, 2021
    Manufacturer
    GSK CONSUMER HEALTH INC
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS GIVEN POLIDENT WITH MY NEW DENTURES IN (B)(6). I STARTED HAVING TROUBLE BREATHING AROUND THE SAME TIME I STARTED USING THIS PRODUCT. I AM DEATHLY ALLERGIC TO PENICILLIN BUT WAS GIVEN THIS PRODUCT BY THE DENTIST THAT MADE THE DENTURES, NO WARNINGS OF ANY KIND. MY BREATHING CONTINUED TO GET WORSE AND ON 2 OCCASIONS I REQUIRED TREATMENT IN THE E.R. NO ONE WAS ABLE TO EXPLAIN THE SUDDEN ONSET OF BREATHING PROBLEMS. WHEN I RAN OUT OF THE SAMPLES, I WAS GIVEN I BOUGHT EFFERDENT BECAUSE IT WAS CHEAPER. I GOT HORRIBLE SORES ALL INSIDE OF MY MOUTH AND WAS UNABLE TO WEAR MY DENTURES FOR SEVERAL DAYS. WHILE MY DENTURES WHERE OUT MY BREATHING GOT BETTER. I ALWAYS RINSE MY DENTURES WELL WITH RUNNING WATER, SO I MADE NO CONNECTION. I WAS RESEARCHING WHAT COULD HAVE CAUSED THE MOUTH SORES AND FOUND SEVERAL WARNINGS ABOUT THE PRODUCTS. I AM CURRENTLY USING ONLY BAKING SODA ON MY DENTURES AND MY RESPIRATORY PROBLEMS HAVE BEEN RELIEVED. I COULD HAVE DIED PLEASE TAKE SOME KIND OF ACTION TO LET PEOPLE KNOW YOU CAN HAVE THESE KIND OF ALLERGIC REACTIONS TO THESE PRODUCTS. HEALTHCARE PROVIDERS SHOULD KNOW AS WELL. I HAVE HAD A GAZILLION TEST AND HAVE BEEN TREATED TWICE IN THE E.R. I WILL RELEASE ANY INFO YOU NEED. PRODUCT TYPE: OVER THE COUNTER. STRENGTH: EFFERVESCENT. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? YES. QUANTITY: 6 TABLET(S). HOW WAS IT TAKEN OR USED? DENTURES SOAKED. GIVE BEST ESTIMATE OF DURATION? 1 MONTH. WHY WAS THE PERSON USING THE PRODUCT? CLEAN DENTURES. QUANTITY: 20 TABLET(S). DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2021. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490629 POLIDENT CLEANSER, DENTURE, OVER THE COUNTER EFT GSK CONSUMER HEALTH INC 993P
    490630 EFFERDENT CLEANSER, DENTURE, OVER THE COUNTER EFT MEDTECH PRODUCTS, INC. 0162626

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O