BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS MONOPOLAR NERVE STIMULATOR PROBE

    MDR report key: 22235450 · Received June 17, 2025

    Report

    Report Number
    MW5171585
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 6, 2025
    Manufacturer
    XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN SCRUB WAS SETTING UP FOR A CASE, SHE NOTICED THAT THE INDICATOR IN PACKAGE WAS NOT THE CORRECT COLOR TO SHOW STERILITY. EQUIPMENT WAS TAKEN OFF NEW FIELD BEFORE REACHED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34395 NATUS MONOPOLAR NERVE STIMULATOR PROBE STIMULATOR, NERVE ETN XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. 017511 241231001B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown