BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSCOE MEDICAL QUATTRO

    MDR report key: 6169912 · Received December 13, 2016

    Report

    Report Number
    3012316249-2016-00014
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 13, 2016
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOTOLOGY CO., LTD
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    SHE WAS TREATING HER PATIENT USING IF-4P, USING 4 2X2 ELECTRODES WHICH WERE BRAND NEW. THE ELECTRODES WERE 3" APART ON THE LOWER BACK. THE PATIENT FELT A BURNING SENSATION, THEY REMOVED THE ELECTRODES AND NOTICED BLISTERING. SHE STATES THE PARAMETERS WERE AT 80 TO 120 HZ YET STATES THE PULSE RATE WAS AT THE DEFAULT. IN IF WE DO NOT HAVE A PULSE RATE DEFAULT OF 80-120, SO THIS MUST BE THEIR REWRITTEN DEFAULT. THE PATIENT IS STILL HEALING FROM THE INJURY THAT OCCURRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823319 ROSCOE MEDICAL QUATTRO TENS UNITS GZJ SHENZHEN DONGDIXIN TECHNOTOLOGY CO., LTD DQ8450

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other