BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL AMALGAM

    MDR report key: 11562524 · Received March 23, 2021

    Report

    Report Number
    MW5100227
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    September 28, 2015
    Report Date
    March 21, 2021
    Manufacturer
    UNK
    Product Code
    EFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A CAVITY FILLED AND INCIDENTALLY THE DENTIST HAD TO REMOVE AN AMALGAM FILLING THAT WAS THERE TO PUT IN A LARGER COMPOSITE FILLING. I HAD A MIGRAINE FOR 9 DAYS AFTER THIS AND SUBSEQUENTLY WAS DIAGNOSED WITH MYASTHENIA GRAVIS AFTER EXPERIENCING A DROOPY EYELID SOON AFTER THE PROCEDURE. I BELIEVE MERCURY EXPOSURE FROM THE DENTAL AMALGAM REMOVAL TRIGGERED MYASTHENIA GRAVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445541 DENTAL AMALGAM DENTAL AMALGAM EFD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability