BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE WITH 20 MODES

    MDR report key: 11154437 · Received January 11, 2021

    Report

    Report Number
    MW5098765
    Event Type
    Injury
    Date Received
    January 11, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 8, 2021
    Manufacturer
    SHENZHEN YUWEN E-COMMERCE CO.,/ SHEN ZHEN AS TEC TECHNOLOGY CO LTD
    Product Code
    NUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURN(S); ERYTHEMA; ITCHING, IT IS A TENS PRODUCT. MODEL NO. AS8012. BOUGHT ON (B)(6) FOR TRAPS AND NECK PAIN. USED ONCE ON A FRIDAY AND WOKE UP SATURDAY WITH SKIN PETECHIAE/ELECTRICAL BURNS ON LEFT HAND AND FOREARM. THE BRAND NAME IS (B)(6). THE PRODUCT LINK IS (B)(6) THE SELLER NAME IS: (B)(4). MANUFACTURER IS: SHENZHEN AS-TEC TECHNOLOGY CO., LTD. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41258 AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE WITH 20 MODES STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH SHENZHEN YUWEN E-COMMERCE CO.,/ SHEN ZHEN AS TEC TECHNOLOGY CO LTD AS8012

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R| S