BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELVIE

    MDR report key: 16442851 · Received February 27, 2023

    Report

    Report Number
    3012098706-2023-00049
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    February 22, 2022
    Report Date
    February 27, 2022
    Manufacturer
    CHIARO TECHNOLOGY
    Product Code
    KXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER HAS STATED "I USED THE TRAINER FOR THE FIRST TIME AND IMMEDIATELY BECAME INFECTED WITH A HORRIBLE URINARY TRACK INFECTION IN LESS THAN 24 HOURS. MY HUSBAND RUSHED ME TO AN URGENT CARE CENTER BECAUSE I WAS LITERALLY URINATING BLOOD WITH LARGE CLOTS". SHE WAS ADVISED BY THE DOCTOR TO DISCONTINUING USING THE TRAINER. CUSTOMER HAS REPORTED FROM US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856686 ELVIE ELVIE TRAINER KXQ CHIARO TECHNOLOGY EL01

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other