BEUDAMED
    FDA Adverse Event Other Summary report: N

    RONDEX

    MDR report key: 18311862 · Received December 12, 2023

    Report

    Report Number
    MW5149131
    Event Type
    Other
    Date Received
    December 12, 2023
    Report Date
    December 12, 2023
    Manufacturer
    SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD.
    Product Code
    ISA
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I FOUND THAT DURING USE THIS PRODUCT MADE ME FEEL VERY PAINFUL. THE CURRENT OF EMS IS NOT SOMETHING THAT HUMANS CAN BEAR. I HAVE A UNDERLYING HEART CONDITION, AND THE INTENSITY OF THIS CURRENT PUT ME IN THE HOSPITAL. I LEARNED THAT THIS TYPE OF PRODUCT IS LISTED ON AMAZON. IT NEEDS TO BE AUDITED BY THE FDA. I WOULD LIKE TO KNOW WHETHER THE FDA HAS ACTUALLY AUDITED THE SELLER'S INFORMATION? BASED ON OUR TRUST IN THE FDA, I AM SENDING THIS EMAIL FOR CONFIRMATION. I HOPE THE FDA CAN SERIOUSLY REVIEW EVERY SELLER. THIS IS THE PROTECTION OF OUR CONSUMERS. IN ADDITION, IT IS UNREASONABLE FOR THIS PRODUCT TO HAVE SO MANY REVIEWS IN A SHORT PERIOD OF TIME, WHICH CAN PROVE THAT IT DECEIVES CONSUMERS THROUGH ILLEGAL BEHAVIORS. AS A MERCHANT WHO OFTEN DECEIVES BUYERS, I HAVE REASON TO SUSPECT THAT HE USES ILLEGAL CHANNELS TO AVOID FDA REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703115 RONDEX MASSAGER, THERAPEUTIC, ELECTRIC ISA SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD. B0CCRLRCXS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown