BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL AMALGAM FILLINGS

    MDR report key: 17119438 · Received June 12, 2023

    Report

    Report Number
    MW5118362
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    January 23, 2023
    Report Date
    June 8, 2023
    Manufacturer
    UNK
    Product Code
    OIV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LABORATORY ELISA KIT WAS USED AND ALL PRODUCTS WERE PLACED IN A BIOHAZARD BIN IN THE LABORATORY. THAT DAY AND THE FOLLOWING DAYS INCREASED ILLNESS AND GOLD CROWN ITCHING UNTIL BINS WERE REMOVED. KITS CONTAIN SODIUM AZIDE. ALTHOUGH KITS CONTAINED A VERY SMALL AMOUNT REACTIONS OCCURRED WITH ACIDS AND OTHER CHEMICALS IN THE BIOHAZARD BINS, AS WELL AS WITH METAL CROWN AND FILLINGS IN MOUTH. WHICH BECAME COMPROMISED AND ARE CAUSING ME SIGNIFICANT HEALTH ISSUES. GOLD CROWN WHICH I STILL HAVE, AND SODIUM AZIDE IN LABORATORY PRODUCT. MOST DENTISTRY AND ALL LABORATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308646 DENTAL AMALGAM FILLINGS DENTAL AMALGAM OIV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Disability| O| R PRENATAL VITAMIN