BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IONTO 4 IONTOPHORETIC STIMULATOR

    MDR report key: 21066027 · Received January 3, 2025

    Report

    Report Number
    21066027
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    August 14, 2024
    Report Date
    December 10, 2024
    Manufacturer
    WR MEDICAL ELECTRONICS CO.
    Product Code
    EGJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (DATE REDACTED), THE PATIENT UNDERWENT AN AUTONOMIC REFLEX TEST. TWO DAYS LATER, THE PATIENT REPORTED THAT SHE NOTICED A BURN MARK ON HER LEFT KNEE THE DAY AFTER THE TEST AND THOUGHT IT WAS POSSIBLY RELATED TO AN ELECTRODE. SHE EXPLAINED THAT THE ELECTRODE ATTACHED TO HER KNEE HAD BEEN ¿BURNING¿ DURING THE TEST. IT IS UNCLEAR IF THE AREA THAT THE PATIENT DESCRIBED AS A SMALL BURN, WAS ASSOCIATED WITH THE AUTONOMIC REFLEX TEST, AND STAFF DO NOT BELIEVE THE ELECTRODE HAD BEEN PLACED IN THIS AREA. HOWEVER, THIS IS NOTED AS A POTENTIAL SIDE EFFECT BY THE MANUFACTURER. DURING THE TEST, THE TECHNOLOGIST WAS NOT AWARE OF ANY COMPLAINT OF PAIN AND DID NOT OBSERVE ANY BLISTERS OR BURNS ON THE PATIENT AFTER THE TEST. THE DEPARTMENT CONFIRMED THAT THE EQUIPMENT WAS WORKING PROPERLY, AND HEALTHCARE TECHNOLOGY MANAGEMENT VERIFIED THAT THE EQUIPMENT PASSED ALL TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427524 IONTO 4 IONTOPHORETIC STIMULATOR DEVICE, IONTOPHORESIS, OTHER USES EGJ WR MEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female