BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUVON TENS UNIT

    MDR report key: 20993667 · Received December 19, 2024

    Report

    Report Number
    MW5163818
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    October 16, 2024
    Report Date
    December 18, 2024
    Manufacturer
    SHEN ZHEN AS TEC TECHNOLOGY CO LTD
    Product Code
    NUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT THE AUVON TENS UNIT FROM AMAZON. USE IT ONCE ON MY LOWER BACK, ONCE I TURNED IT ON, IT ZAPPED THE HECK OUT OF ME DESPITE SETTING THE POWER TO ZERO, THE DEVICE DELIVERED A STRONG ELECTRICAL SHOCK UPON ACTIVATION. THIS UNEXPECTED BEHAVIOR POSES A SERIOUS SAFETY RISK AND INDICATES A POTENTIAL DEFECT IN THE DEVICE. AFTER A 20-MINUTE SESSION AT 20% POWER, I REMOVED THE PROBES AND NOTICED A BRUISED-LOOKING MARK ON MY LOWER BACK. THIS SUGGESTS THAT THE DEVICE MAY BE DELIVERING CURRENTS THAT ARE TOO STRONG FOR SAFE APPLICATION. THE MANUFACTURER'S NAME IS SHEN ZHEN AS TEC TECHNOLOGY CO LTD, THE 510K NUMBER IS K200727 AND K143268; ALL OF THESE PRODUCTS ARE NON-COMPLIANT. MANDATE THE IMMEDIATE REMOVAL OF THE PRODUCT FROM AMAZON AND OTHER RETAILERS, PLEASE CHECK BELOW ASINS AND MODELS. I BELIEVE THAT PROMPT ACTION BY THE FDA IS CRUCIAL TO PROTECT THE HEALTH AND SAFETY OF POTENTIAL USERS OF THIS DEVICE. THANK YOU FOR YOUR ATTENTION TO THIS MATTER. ASIN: B07D58V8LD MODEL? : ? AS8012 ASIN: B07KTV52K1 MODEL? : ? AS8012 ASIN: B085TL8TPJ MODEL: AS8012C ASIN: B06ZZ19MS3 MODEL: AS8010 ASIN: B08FLWZT16 MODEL: AS8016 ASIN: B0CQ2DLXDJ MODEL: AS8019 ASIN: B0D12W9QX6 MODEL:TA2224 ASIN: B0CJ55LH2N MODEL: TA3224. I BOUGHT THE AUVON TENS UNIT FROM AMAZON. USE IT ONCE ON MY LOWER BACK, ONCE I TURNED IT ON, IT ZAPPED THE HECK OUT OF ME DESPITE SETTING THE POWER TO ZERO, THE DEVICE DELIVERED A STRONG ELECTRICAL SHOCK UPON ACTIVATION. THIS UNEXPECTED BEHAVIOR POSES A SERIOUS SAFETY RISK AND INDICATES A POTENTIAL DEFECT IN THE DEVICE. AFTER A 20-MINUTE SESSION AT 20% POWER, I REMOVED THE PROBES AND NOTICED A BRUISED-LOOKING MARK ON MY LOWER BACK. THIS SUGGESTS THAT THE DEVICE MAY BE DELIVERING CURRENTS THAT ARE TOO STRONG FOR SAFE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627856 AUVON TENS UNIT STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH SHEN ZHEN AS TEC TECHNOLOGY CO LTD AS8012

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other