BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTGUARD PREMIUM CLEANER

    MDR report key: 15282681 · Received August 23, 2022

    Report

    Report Number
    MW5111664
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 20, 2022
    Manufacturer
    SMARTGUARD RX INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I STARTED USING A DENTURE CLEANER IN (B)(6) OF 2022 WHICH CONTAINS A PERSULFATE. I DID NOT KNOW THIS WAS POTENTIALLY TOXIC. I USED THE PRODUCT AS INSTRUCTED ON DENTAL RETAINERS. IT TOOK TWO MONTHS FOR SYMPTOMS TO BEGIN SHOWING. PAIN THROUGHOUT MY BODY INCLUDING SEVERE STIFFNESS WHICH WAS UNEXPLAINED AND FOR NO APPARENT REASON AT THE TIME. IT WAS ALSO CAUSING RECURRING PROBLEMS WITH MEMORY AND BRAIN FOG. I HAD A BATTERY OF BLOOD TESTS AND A THERMOGRAM WHICH SHOWED IRRITATION OF MY GUMS THAT OF WHICH I DIDN'T FEEL BUT SHOWED UP ON THE REPORT. TESTS SHOWED NO BODY INFLAMMATION. X-RAYS SHOWED NO SIGNS OF ARTHRITIS. A NERVE CONDUCTION STUDY SHOWED NO SIGNS OF ISSUES INVOLVING TISSUE OR MUSCULAR FUNCTION. I ALSO TOOK A HEAVY METAL AND TOXICITY WORK UP. THOSE RESULTS HAVEN'T BEEN PRODUCED YET BUT I'M STILL WAITING. AFTER REVIEWING ALL OF THE EVIDENCE, I DECIDED TO DO SOME RESEARCH ON THE INGREDIENTS OF THE DENTURE CLEANER AS THAT WAS THE ONLY NEW PRODUCT I CAME IN CONTACT DURING THIS TIME. WHEN A WEEK OF STOPPING THE USAGE OF THIS PRODUCT, THE PAIN HAS DIMINISHED GREATLY ALTHOUGH NOT COMPLETELY GONE. I SUSPECT THE PERSULFATE IS THE CULPRIT. REASON FOR USE: CLEAN DENTAL RETAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202825 SMARTGUARD PREMIUM CLEANER CLEANSER, DENTURE, OVER THE COUNTER EFT SMARTGUARD RX INC. 024514M

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other| R