BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUDO SCAN

    MDR report key: 20451995 · Received October 11, 2024

    Report

    Report Number
    MW5161010
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 27, 2024
    Report Date
    October 5, 2024
    Manufacturer
    SUDOSCAN / IMPETO MEDICAL
    Product Code
    GZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6), I WENT TO SEE A NEUROLOGIST DR (B)(6) AT (B)(6) FOR HIP ISSUE. I WAS FORCED TO UNDERGO A TEST ON A MACHINE CALLED SUDO SCAN. POST THAT TEST THE FACE OF THE FOOT HAS BEEN CRAMPING, HEATED AND IS GETTING DRY. THIS TEST WAS UNNECESSARY AND NOW I AM HAVING DIFFICULTY WAKING, DRIVING AS I FEEL PINS AND NEEDLES, PAIN, CRAMPING AND LOSS OF SENSATION. I DID NOT HAVE ANY SUCH ISSUES BEFORE. DOCTOR JUST SAID IT IS SAFE AND IT IS FDA APPROVED. I WANT TO PROVIDE THAT IT IS NOT SAFE AND PERHAPS THE MACHINE IS NOT SAFE FOR EVERYONE. I WOULD LIKE THIS TO BE INVESTIGATED. THE DOCTOR HAS THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352178 SUDO SCAN DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT GZO SUDOSCAN / IMPETO MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other MULTIVITAMIN.