BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCH OSANA COVID TEST KIT

    MDR report key: 20480907 · Received October 17, 2024

    Report

    Report Number
    MW5161210
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 13, 2024
    Manufacturer
    OSANG HEATLHCARE/OSANG LLC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED TEST KITS FROM THE UNITED STATES POST OFFICE FOR COVID. I CHECKED THE EXPIRATION DATE EXTENSION AND THEY ARE SCHEDULED TO EXPIRE IN DECEMBER OF THIS YEAR HOWEVER I TESTED RECENTLY AND I GOT NEGATIVE REPEATEDLY AS DID MY SON WHO LIVES WITH ME. WE BOTH HAD COVID SYMPTOMS INCLUDING MY SON'S LOST OF TASTE AND SMELL. NEITHER OF US HAD FEVERS BUT WE WERE BOTH FATIGUED AND HAD SOME MINOR BREATHING PROBLEMS. I'M AFRAID THESE OCH BRAND OF TEST KITS ARE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230722 OCH OSANA COVID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP OSANG HEATLHCARE/OSANG LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male