BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELIFU DUAL CHANNEL TENS EMS UNIT 24 MODES MUSCLE STIMULATOR FOR PAIN RELIEF THE

    MDR report key: 10991679 · Received December 10, 2020

    Report

    Report Number
    MW5098317
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    April 20, 2020
    Report Date
    December 8, 2020
    Manufacturer
    SHENZHEN HONGQIANGXING / SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
    Product Code
    GZJ
    UDI-DI
    00321911080500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT IS A TENS PRODUCT. BOUGHT ON (B)(6) FOR TRAPS AND NECK PAIN. USED ONCE ON A FRIDAY AND WOKE UP SATURDAY WITH SKIN PETECHIA/ELECTRICAL BURNS ON LEFT HAND AND FOREARM. THE PRODUCT LINK IS (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447277 BELIFU DUAL CHANNEL TENS EMS UNIT 24 MODES MUSCLE STIMULATOR FOR PAIN RELIEF THE STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF GZJ SHENZHEN HONGQIANGXING / SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED TENS 00321911080500

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other