BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVID-19 ANTIGEN HOME TEST

    MDR report key: 15825564 · Received November 17, 2022

    Report

    Report Number
    MW5113344
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    November 15, 2022
    Report Date
    November 15, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REBOUND COVID-19 TEST AFTER ANTI-VIRAL, MOLNUPIRAVIR. REGULAR COURSE OF TX, 2 NEGATIVE TESTS. NEXT DAY TESTED POSITIVE AGAIN. ONLY SYMPTOMS PRODUCTIVE COUGH AND MILD MALAISE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372007 COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2010023
    1372008 COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2010023

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other AMLODIPINE| AORTIC HEART VALVE | LOSARTIN/HCTZ| METOPROLOL| PACEMAKER| VITAMIN D| WARFARIN