BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVID HOME ANTIGEN TEST

    MDR report key: 16939635 · Received May 15, 2023

    Report

    Report Number
    MW5117543
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REBOUND COVID AFTER 5 DAYS OF PAXLOVID. OCCURRED 2 DAYS AFTER A NEGATIVE ANTIGEN TEST. (+) HOME ANTIGEN TEST 2 DAYS FOLLOWING A (-) TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817920 COVID HOME ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male PAXLOVID