BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-WAVE

    MDR report key: 17810348 · Received September 22, 2023

    Report

    Report Number
    MW5146113
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    September 20, 2023
    Report Date
    September 20, 2023
    Manufacturer
    ELECTRONIC WAVEFORM LAB, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING THE H-WAVE DEVICE AS PER INSTRUCTIONS ON A VIDEO CONFERENCE WITH AN H-WAVE REPRESENTATIVE. THE DEVICE CAUSED SEVERE PAIN IN MY JOINTS THAT WERE IN THE TREATMENT AREA AS WELL AS A SEVERE BURNING SENSATION IN MY SPINE OUTSIDE OF THE TREATMENT AREA, AND A MIGRAINE. THESE EFFECTS HAVE LASTED, THUS FAR, FOR 3 HOURS, AND HAVE NO INDICATION OF REDUCING, DESPITE TAKING PAIN RELIEVING MEDICATIONS SUCH AS CODEINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568426 H-WAVE STIMULATOR, MUSCLE, POWERED IPF ELECTRONIC WAVEFORM LAB, INC. H4

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention CODEINE.| FOLATE.| IBUPROFEN.| MAGNESIUM.| MONTELUKAST.| TIZANIDINE.