BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVERITY

    MDR report key: 6809037 · Received August 21, 2017

    Report

    Report Number
    3012316249-2017-00104
    Event Type
    Injury
    Date Received
    August 21, 2017
    Report Date
    August 21, 2017
    Manufacturer
    JKH HEALTH CO., LTD.
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE CUSTOMER, "I'VE RECEIVED A COUPLE OF COMPLAINTS ABOUT THIS ITEM. I'VE HAD TWO SEPARATE PEOPLE USE THEM AND GET BURNT FROM THE UNIT." THE CUSTOMER STATED THAT NONE OF THE DEVICES WERE RETURNED, AND THEY WERE ALL CASH SALES, SO HE DOES NOT HAVE ANY CONSUMER NAMES OR ADDRESSES TO OBTAIN FURTHER INFORMATION FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588486 VIVERITY ELECTROTHERAPY DEVICE GZJ JKH HEALTH CO., LTD. E100-6R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other