BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON GO COVID ANTIGEN SELF TEST KIT

    MDR report key: 14397105 · Received May 12, 2022

    Report

    Report Number
    MW5109665
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 10, 2022
    Manufacturer
    ACCESS BIO INCORPORATE
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SWAB BROKE AND WAS LODGED IN THE CHILD'S NOSE (WHICH HAD TO BE REMOVED BY A PEDIATRIC ENT AS AN EMERGENCY). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387164 ON GO COVID ANTIGEN SELF TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESS BIO INCORPORATE CP21L59

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Required Intervention