BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URITEST UTI TEST STRIPS

    MDR report key: 17712105 · Received September 7, 2023

    Report

    Report Number
    MW5145384
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Report Date
    September 2, 2023
    Manufacturer
    HEALTHYWISER, LLC.
    Product Code
    LJX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EVERY TIME I USED THE PRODUCT IT WOULD SHOW A TRACE AMOUNT OF A UTI(URINARY TRACT INFECTION) BUT WHEN I WOULD GO TO THE DOCTOR AFTER THE TEST I WOULD HAVE A FULL-BLOWN UTI THAT NEEDED ANTIBIOTICS, THIS HAPPENED EVERY TIME USING THESE TEST STRIPS, ALWAYS THE SAME READING. USING THESE TEST STRIPS, I CONSISTENTLY HAD A TRACE AMOUNT OF BACTERIA CAUSING UTIS. EACH TIME I DID IT, I RECEIVED THE SAME RESULTS, THEN WOULD GO TO THE DOCTOR AND HAVE A FULL-BLOWN UTI, NOT JUST A TRACE AMOUNT THAT ENDED UP NEEDING ANTIBIOTICS. THIS HAPPENED EVERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118610 URITEST UTI TEST STRIPS TEST, URINE LEUKOCYTE LJX HEALTHYWISER, LLC. URS-1-2106-01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female ABILIFY 30MG/DAY.| GEODON 180MG/DAY.| HYDROCHLOROTHIAZIDE 12.5MG/DAY.| METAPROLOL 25MG/DAY.| MOBIC 7.5MG/DAY.| WELLBUTRIN 300 MG/DAY.