BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LG 8TM ELITE

    MDR report key: 6084069 · Received November 7, 2016

    Report

    Report Number
    3005182235-2016-00040
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 7, 2016
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED REGARDING HER ORDER, AND MENTIONED THAT SHE HAD PURCHASED THE HYPOALLERGENIC ELECTRODES TO TRY. SHE STATED THAT SHE NOTICED BLISTERS, AND WASN'T SURE IF THEY WERE CAUSED BY HER ELECTRODES OR USING HER DEVICE ALL THE TIME. PER THE COMPASS HEALTH BRANDS CUSTOMER SERVICE REPRESENTATIVE THAT TOOK CARE OF THIS CUSTOMER, IT IS UNCLEAR WHETHER THE CUSTOMER/END-USER IS UNDER CARE, BUT IS COMPLAINING ALL THE TIME ABOUT NOT FEELING WELL. CUSTOMER/END-USER MENTIONED THAT THE DEVICE/ELECTRODES WERE USED IN PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734437 LG 8TM ELITE TENS UNIT GZJ SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. DS5419 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R