BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL AMALGAM

    MDR report key: 11976129 · Received June 9, 2021

    Report

    Report Number
    MW5101814
    Event Type
    Injury
    Date Received
    June 9, 2021
    Report Date
    June 7, 2021
    Product Code
    OIV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM ALLERGIC TO SILVER AND I HAVE O- BLOOD. I'M ALLERGIC TO A LOT OF MEDICATIONS. I HAD DENTAL AMALGAM FILLINGS AS A CHILD. IN 2018 MY TEETH STARTED TO DECAY. SINCE THEN I HAVE BEEN HAVING ADVERSE REACTIONS THAT YOU POSTED ON YOUR PAGE OF MEDICAL DEVICES ON (B)(6)2020. ALSO WHEN I BREATHE ON MY ARMS, MY ARMS TINGLE AND BREAK OUT LIKE REALLY BAD REACTIONS. I BELIEVE IT WAS MADE BY THE MERCURY, COPPER, SILVER, TIN, AND ZINC THAT IS PUT IN THE DENTAL AMALGAM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868184 DENTAL AMALGAM DENTAL AMALGAM OIV

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S