BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELVIE

    MDR report key: 15535119 · Received October 4, 2022

    Report

    Report Number
    3012098706-2022-00025
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 4, 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 ALLEGED THAT THEY DEVELOPED YEAST INFECTION AFTER USING ELVIE TRAINER. ORAL MEDICATION WAS PRESCRIBED TO THE CUSTOMER BY GYNAECOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768040 ELVIE ELVIE TRAINER KXQ CHIARO TECHNOLOGY EL01

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other