BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE

    MDR report key: 11170158 · Received January 13, 2021

    Report

    Report Number
    MW5098822
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    January 10, 2021
    Report Date
    January 12, 2021
    Manufacturer
    SHENZHEN AS-TEC TECHNOLOGY CO LTD
    Product Code
    NUH
    UDI-DI
    06971292001201
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT NAME IS AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE? MODEL NO. AS8012; I BOUGHT IT ON (B)(6), THE LINK IS: (B)(6) PROBLEM: I GOT A SHARP PAIN WHEN I AM USING THE TENS UNIT AND SAW THE PADS LEFT MILD BURNS ON MY SKIN. IT IS LIKE ALLERGY SYMPTOMS AND THE SKIN WAS ITCHING AND REDNESS FOR SEVERAL DAYS AND RECOVERED IF I STOPPED USING IT. BUT IF I RESTART USING IT, IT LEFT BURNS ON THE SKINS AGAIN. COMPANY NAME IS SHENZHEN YUWEN E-COMMERCE CO., LTD. MANUFACTURER: SHENZHEN AS-TEC TECHNOLOGY CO, LTD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64626 AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH SHENZHEN AS-TEC TECHNOLOGY CO LTD AS8012 AUAS20200824001 06971292001201

    Patients

    Seq Age Sex Outcome Treatment
    1