BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX)

    MDR report key: 17852263 · Received September 29, 2023

    Report

    Report Number
    MW5146298
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 15, 2023
    Manufacturer
    IHEALTH LABS, INC.
    Product Code
    QKP
    UDI-DI
    20856362005894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 I OPENED UP A SEALED TEST KIT (COVID) ANTIGEN COVID-19 RAPID TEST. THE TEST KIT IS MANUFACTURED FOR IHEALTH LABS INC., 120 SAN LUCAR CT, SUNNYVALE, CA 94086; 1-855-816-7705. UPON OPENING THE SEALED SWAB TEST STICK TO INSERT IN EACH NOSTRIL, I IMMEDIATELY SMELLED A VERY STRONG CHEMICAL ODOR ON THE SEALED SWAB, AFTER SWAB INSERTED, THE INSIDE OF MY NOSTRILS AND THEN CAUSED ME TO CHOKE, SNEEZE, GASP FOR AIR, DROOL, WATERY EYES AND UNABLE TO BREATHE OR SWALLOW FOR APPROX. 1 MINUTE OR LONGER. I THOUGHT I WAS GOING TO CHOKE TO DEATH BECAUSE I COULD NOT SWALLOW AFTER A MINUTE OR SO, I WAS ABLE TO SWALLOW, BUT THE INCIDENT WAS SO TERRIFYING BECAUSE OF THE SIDE EFFECT FROM THE SEALED SWAB. I CALLED COMPANYON (B)(6) 2023, THEY SAID MY BOXES (3) WERE COUNTERFEIT. REFER REPORTS: MW5146297, MW5146299.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099677 COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP IHEALTH LABS, INC. ICO-3000 (10)221C020820 20856362005894

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female CARBOXYMETHYLCELLULOSE EYEDROPS 0.5%.| CHOLECALCIF 10MGG VITAMIN D. | CLOBETASOL PROPIONATE CREAM 0.05%.| IBUPROFEN 800 MG (AS NEEDED). | LEVOTHYROXINE (SYNTHROID) 75 MCG. | VIACTIVE 650MG (CALCIUM).| VITAMIN B12.