BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHWISER UTI TEST STRIPS

    MDR report key: 17698592 · Received September 6, 2023

    Report

    Report Number
    MW5145270
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Report Date
    September 1, 2023
    Manufacturer
    HEALTHYWISER, LLC
    Product Code
    LJX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    KNEW THESE TEST STRIPS WERE FAKE OR DEFECTIVE AND GIVING FALSE NEGATIVE RESULTS ON UTI INFECTIONS WHEN I HAD A UTI. EVERY SINGLE TEST STRIP WAS GIVING A NEGATIVE RESULT WHEN IT SHOULD HAVE READ POSITIVE. SELLER COULD NOT BE REACHED ON AMAZON AND AMAZON WOULD NOT ACCEPT A RETURN AFTER 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120872 HEALTHWISER UTI TEST STRIPS TEST, URINE LEUKOCYTE LJX HEALTHYWISER, LLC URS-1-2210-01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female