BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODIAGNOSTIC FUNCTIONAL ASSESSMENT (EFA) EFA-STM

    MDR report key: 12583314 · Received October 5, 2021

    Report

    Report Number
    MW5104411
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    June 7, 2021
    Report Date
    October 2, 2021
    Manufacturer
    EMERGE DIAGNOSTICS, INC.
    Product Code
    IKN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS TESTED THROUGH THE COMPANY (B)(6) ON SITE AT MY EMPLOYER'S LOCATION IN (B)(6). I EXPERIENCED BRUISING, TORN SKIN AND RASHES FROM WHERE THE ELECTRODES WERE PLACED AND TAKEN OFF MY SKIN. THE INDIVIDUAL DID NOT PROVIDE THEIR NAME OR THEIR MEDICAL CREDENTIALS BUT STATED THAT THE BRUISING, LITTLE SKIN TEARS AND RASH WOULD JUST GO AWAY AND TO PUT A BANDAID ON THE AREAS. AFTER THE TEST WAS OVER, I ASKED WHO COULD CONTACT ABOUT THE TEST RESULTS OR IF I HAVE ANY QUESTIONS. THE TECH STATED THAT THERE WAS NO ONE TO CONTACT AND TO TALK TO MY EMPLOYER. I TRIED TO CONTACT THE COMPANY BUT I GOT THEIR "OUTSIDE" ANSWERING PHONE SERVICE. AFTER THE FIFTH CALL, I GAVE UP. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472264 ELECTRODIAGNOSTIC FUNCTIONAL ASSESSMENT (EFA) EFA-STM ELECTROMYOGRAPH, DIAGNOSTIC IKN EMERGE DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1