BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO 2.5

    MDR report key: 6563110 · Received May 12, 2017

    Report

    Report Number
    3012316249-2017-00050
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    April 14, 2017
    Report Date
    May 12, 2017
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THREE PEOPLE WERE BURNED WHILE USING THE ELECTROTHERAPY DEVICE - THIS REPORT IS BASED ON ONE OF THE THREE REPORTED-BURNED PATIENTS. THE DOCTOR IS REPORTED AS USING POOR ELECTRODES, AND OTHER DEVICES HE HAS RETURNED HAVE BEEN IN POOR CONDITION. WHEN COMPASS HEALTH BRANDS WAS ABLE TO SPEAK WITH THE DOCTOR, THE DOCTOR HAD MENTIONED THAT EACH PATIENT WAS BURNED WITH THE SAME BRAND OF ELECTRODE. THIS PATIENT'S BURNS SHOWED UP ON HER SKIN IMMEDIATELY, AND LASTED FOR ONE MONTH. THE DEVICE WAS RETURNED TO COMPASS HEALTH BRANDS AND EVALUATED ON 5/9/2017. THE CUSTOMER'S COMPLAINT COULD NOT BE DUPLICATED. THE DEVICE WAS TESTED FOR PRODUCT PERFORMANCE, AND DETERMINED TO FALL WITHIN THE MANUFACTURER'S SPECIFICATIONS, AS DEFINED IN THE PRODUCT USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344833 QUATTRO 2.5 ELECTROTHERAPY DEVICE GZJ SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. DQ8450

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other