BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID RAPID TESTING

    MDR report key: 15986909 · Received December 14, 2022

    Report

    Report Number
    MW5113786
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    December 6, 2022
    Report Date
    December 12, 2022
    Manufacturer
    GENABIO DIAGNOSTICS INC.
    Product Code
    QMN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I OPENED A CORONA VIRUS TEST AND TOUCHED AN OPEN SWAB WITH THE BROWN FECAL-LOOKING MATTER ON IT. I CONTACTED THE COMPANY WITH LOT NUMBER. DATE OF USE: (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626649 COVID RAPID TESTING COVID-19 MULTI-ANALYTE ANTIGEN DEVICE QMN GENABIO DIAGNOSTICS INC. US220925

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other MULTIVITAMINS