BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVIEW STREP A TEST KIT

    MDR report key: 16573043 · Received March 17, 2023

    Report

    Report Number
    MW5115811
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    March 14, 2023
    Report Date
    March 15, 2023
    Manufacturer
    WONDFO USA CO., LTD.
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED THE PREVIEW STREP A TEST KIT (10 TESTS) AND WHEN I WENT TO GIVE MY DAUGHTER ONE OF THE TESTS, THE BOTTLE MARKED 'A - EXTRACTION REAGENT' WAS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825138 PREVIEW STREP A TEST KIT ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY WONDFO USA CO., LTD. B03920702 A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female