BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIY DENTURE KIT

    MDR report key: 11938556 · Received June 3, 2021

    Report

    Report Number
    MW5101708
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    June 2, 2021
    Manufacturer
    UNK
    Product Code
    EBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DIY DENTURE KIT. THIS PRODUCT IS HARMFUL FOR PATIENT AND WILL CAUSE DAMAGE AND INJURY THAT WILL REQUIRE THOUSANDS OF DOLLARS IN DENTISTS FEE TO REPAIR DAMAGE IF POSSIBLE AT ALL. DIY(B)(6); FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832058 DIY DENTURE KIT DENTURE REPAIR KIT EBO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other