BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZO

    MDR report key: 888616 · Received July 30, 2007

    Report

    Report Number
    MW5003218
    Event Type
    Malfunction
    Date Received
    July 30, 2007
    Date of Event
    July 27, 2007
    Report Date
    July 30, 2007
    Manufacturer
    AMERIFIT
    Product Code
    JJW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2007, I PURCHASED AZO TEST STRIPS FOR URINARY TRACT INFECTIONS TO TEST ON MY DAUGHTER, SHE WAS RUNNING A TEMP AND HER DOC THOUGHT SHE MAY HAVE A UTI. WHEN I TESTED HER URINE IT SHOWED POSITIVE, SO I TOOK HER TO AN AFTER HOURS ER WHEN THEY TESTED HER, IT WAS NEGATIVE. WHICH MEANT THE AZO TEST STRIP WAS WRONG, ONCE I GOT HOME, I USED ANOTHER TEST STRIP TO CHECK MY OWN URINE WHICH ALSO SHOWED POSITIVE AND I DO NOT HAVE A UTI, SO I HAD MY HUSBAND USE THE THIRD TEST STRIP TO CHECK HIS AND LOW AND BEHOLD HIS WAS ALSO POSITIVE AND HE DOESN'T HAVE A UTI EITHER. I FEEL THIS COMPANY HAS THESE TEST STRIPS WHICH SHOW POSITIVE EVEN WHEN THEY SHOULD BE NEGATIVE SO THAT CONSUMERS WILL GO BACK AND BUY MORE OF THEIR PRODUCTS. DATES OF USE: ONE DAY IN 2007. DIAGNOSIS OR REASON FOR USE: POSSIBLE UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AZO TEST STRIPS JJW AMERIFIT 5L01E

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Other URINARY TRACT INFECTION TEST STRIPS