BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

    MDR report key: 23026826 · Received September 11, 2025

    Report

    Report Number
    MW5175906
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    August 13, 2025
    Report Date
    August 21, 2025
    Manufacturer
    MOLUFEIBE
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER USING IT, MY SKIN BECAME RED, ITCHY, AND EVEN HAD SMALL BLISTERS. I BELIEVE THIS PRODUCT HAS SERIOUS QUALITY ISSUES. ELECTRODE PATCHES ARE SUPPOSED TO BE MEDICAL PRODUCTS, AND I'M NOT SURE IF THIS PRODUCT MEETS THOSE REQUIREMENTS. PATIENT:1840, 4537, 1943. DEVICE:2682. REFERENCE REPORTS: MW5175904, MW51795905.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675440 STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX MOLUFEIBE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown