BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVID-19 "CORONAVIRUS" IGG / IGM RAPID TEST KIT

    MDR report key: 9957564 · Received April 14, 2020

    Report

    Report Number
    MW5094128
    Event Type
    Injury
    Date Received
    April 14, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 11, 2020
    Manufacturer
    PHAMATECH INC
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    WE ARE GRAVELY CONCERNED THAT PHAMATECH IS SELLING UNPROVEN AND UNRELIABLE (B)(6) MADE SEROLOGY TESTS TO THE GENERAL PUBLIC, WHICH SHOULD ONLY BE SOLD THROUGH HCP. THEY ARE ALSO MISLABELING THE PRODUCT. PHAMATECH IS MISLABELING THE PRODUCT AND SELLING IT TO ANYONE WHO WALKS IN. PLEASE STOP THEM. HERE IS THE COMPANY'S WEBSITE: HTTPS://WWW.PHAMATECH.COM/INDEX3.PHP/. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419716 COVID-19 "CORONAVIRUS" IGG / IGM RAPID TEST KIT REAGENT, CORONAVIRUS SEROLOGICAL QKO PHAMATECH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention