BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 6249592 · Received January 13, 2017

    Report

    Report Number
    3012316249-2017-00006
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 19, 2016
    Report Date
    February 20, 2017
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO COMPASS HEALTH BRANDS ON 1/26/2017. THE DEVICE WAS TESTED WITHIN SPECIFICATION RANGE - NO DEFECTS/FAILURES WERE FOUND. COMPASS HEALTH BRANDS WAS UNABLE TO DUPLICATE/CONFIRM THE CUSTOMER'S COMPLAINT.

    Description of Event or Problem · 1

    THE DOCTOR CALLED IN, STATING HE HAS HAD A PATIENT BURNED WHILE BEING TREATED WITH THE QUATTRO 2.5 DEVICE. THE DOCTOR STATED HE WAS USING IF-4P WITH 2 ELECTRODES - WHICH IS SOMETHING YOU JUST DON'T DO. HE HAD EACH ELECTRODES ON ONE TRAP MUSCLE, TOO FAR APART. THE COMPASS HEALTH BRANDS CUSTOMER SERVICE REPRESENTATIVE THAT WORKED ON THIS CASE MENTIONED TO THE DOCTOR THAT YOU HAVE TO USE 4 ELECTRODES WITH THIS THERAPY, AND THE DOCTOR IS REPORTED AS HAVING BEGUN TO RECANT HIS STATEMENT, STATING THAT THEY WERE POSSIBLY USING 4 ELECTRODES - THEN HE SAID THEY WERE MOST LIKELY USING IF-4P - HIS INFORMATION DID NOT FLOW. THE DOCTOR STATED THE PATIENT DID NOT FEEL ANY DISCOMFORT DURING THE TREATMENT. THE BURNS WERE NOTICED WHEN THE ELECTRODES WERE REMOVED. THE END-USER IS NOT REPORTED AS HAVING SOUGHT AFTER OR RECEIVED MEDICAL ATTENTION FOR HIS INJURY, HOWEVER, PER PICTURES PROVIDED OF THE BURNS, BLISTERS ARE EVIDENT & THE BURNS WERE REPORTED AS HAVING STILL BE PRESENT AT THE TIME COMPASS HEALTH BRANDS WAS NOTIFIED OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34247 N/A N/A GZJ N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other