BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDRA TOMAC

    MDR report key: 23546678 · Received November 12, 2025

    Report

    Report Number
    MW5178883
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    August 1, 2025
    Report Date
    November 11, 2025
    Manufacturer
    NOCTRIX HEALTH, INC.
    Product Code
    QWD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERSON IS USING NOCTRIX BRAND NIDRA TOMAC SYSTEM (LEG BANDS) FOR TREATMENT OF RESTLESS LEG SYNDROME. PATIENT NOTED 2 DEEP WOUNDS DESCRIBED AS BURNS TO THE SITES OF THE CHARGE DISPENSING INTERFACES. PATIENT REPORTED WEARING DEVICE FOR 30 MINUTES AND DID NOT FEEL ANY PAIN. PATIENT REPORTED NOTICING WOUND UPON REMOVING THE BANDS. PATIENT ALSO REPORTED NOT FOLLOWING INSTRUCTIONS TO CHANGE ADHESIVE PADS IN BETWEEN SESSIONS BECAUSE THEY WERE STILL STICKING TO THE SKIN WELL. PATIENT DID NOT REPORT EVENT TO THE PRESCRIBING DOCTOR FOR MORE THAN 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954828 NIDRA TOMAC STIMULATOR, NERVE, FOR RESTLESS LEGS SYNDROME QWD NOCTRIX HEALTH, INC. A270325

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other