BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELVIE

    MDR report key: 19476768 · Received June 6, 2024

    Report

    Report Number
    3012098706-2024-00040
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 6, 2024
    Manufacturer
    CHIARO TECHNOLOGY
    Product Code
    KXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS CONFIRMED THAT THEY HAVE DEVELOPED A PARASITIC INFECTION AND THAT THEY CAN NOT BE CERTAIN OF THE ORIGIN OF INFECTION. THE CUSTOMER HAS QUESTIONED WHETHER THE DEVICE HAS BEEN REUSED. THE CUSTOMER HAS NOT YET RESPONDED TO CONFIRM WHETHER MEDICAL INTERVENTION AND OR TREATMENT WAS REQUIRED. THE CUSTOMER HAS BEEN ASKED TO PROVIDE FURTHER INFORMATION, SUCH AS THE SERIAL NUMBER AND THE PACKAGING THAT THE DEVICE WAS RECEIVED IN; FOR EXAMPLE, THE PRESCENCE OF SHRINK WRAP. THE CUSTOMER HAS ALSO BEEN ASKED TO CONFIRM WHERE THE DEVICE WAS PURCHASED FROM, TO DETERMINE THAT THE PURCHASED PRODUCT IS FROM AN AUTHORISED SELLER. TO DATE, NONE OF THE ABOVE QUESTIONS HAVE BEEN ANSWERED. CHIARO WILL CONTINUE TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION. IF ANY ADDITIONAL FINDINGS ARE DETERMINED FROM THIS INVESTIGATION, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ON (B)(6) 2024 FROM THE US THAT THE ELVIE TRAINER HAD POTENTIALLY CAUSE AN INFECTION. THE CUSTOMER STATED THAT THEY HAD RECEIVED THE PRODUCT AND CLEANED IT, HOWEVER, THEY BEGAN TO DEVELOP SYMPTOMS AND WERE DIAGNOSED WITH A PARASITIC INFECTION. THE CUSTOMER WENT ON TO SAY THAT IT COULD NOT BE DETERMINED WHETHER THE TRAINER WAS THE CAUSE OF THE INFECTION, HOWEVER, THEY WERE CONCERNED THAT THEY MAY HAVE RECEIVED A USED PRODUCT. THE CUSTOMER HAS NOT YET RESPONDED TO CONFIRM WHETHER MEDICAL INTERVEMTION OR TREATMENT WAS REQUIRED, HOWEVER, THIS WILL BE REPORTED OUT OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980306 ELVIE TRAINER KXQ CHIARO TECHNOLOGY EL01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other