BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDRA BAND

    MDR report key: 23726426 · Received December 4, 2025

    Report

    Report Number
    MW5179921
    Event Type
    Injury
    Date Received
    December 4, 2025
    Report Date
    December 2, 2025
    Manufacturer
    NOCTRIX HEALTH, INC.
    Product Code
    QWD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: IT WAS REPORTED THE CALLER SPOKE WITH A PATIENT WHO HAS RESTLESS LEGS AND USES THE NIDRA BANDS FOR TREATMENT PRN. SHE STATES SHE USED IT ONCE SINCE HER IMPLANT AND NOTICED SIGNIFICANT LEG CRAMPS AFTER USING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438691 NIDRA BAND STIMULATOR, NERVE, FOR RESTLESS LEGS SYNDROME QWD NOCTRIX HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown